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Abstract: Despite rising rates of substance use disorders (SUD) in women and the narrowing of the SUD gender prevalence ratio in the U.S., large knowledge gaps in gender-specific treatment remain. The NIDA Clinical Trials Network (CTN) Gender Special Interest Group (GSIG) has provided opportunities to bring the gender lens to national multi-site clinical trials, ancillary studies, secondary data analyses, recommendations for data collection and demographic data, among other contributions to CTN and the SUD treatment field. This commentary provides background on gender differences and the knowledge gap, a history of the CTN GSIG, and its accomplishments via gender specific trials and key secondary analyses. The commentary will close with future directions and recommendations for research including improving the inclusion of intersectional identities in recruitment reach and analyses, reproductive health, pregnant and parenting people, and methodological considerations for clinical trials to enhance capacity to collect and understand data related to gender.

Abstract:

This brochure, intended for clinicians participating in the CTN-0013 clinical trial (MET to Improve Treatment Utilization and Outcome in Pregnant Substance Users), provides an overview of Motivational Enhancement Therapy (MET) and answers to questions participants might have about being involved in the research project.

Abstract:

The opioid epidemic continues to evolve and impact all groups of people. Moreover, there are concerning trends among women. The aim of this article is to provide a review of opioid use disorder in women and the implications for treatment.

The NIDA Clinical Trials Network Gender Special Interest Group (SIG), a group comprised of investigators and providers from throughout the network, conducted a nonsystematic review of the literature to examine: 1) the epidemiology of opioid-related hospitalizations and deaths of women; 2) co-occurring pain, anxiety disorders, and trauma among women with opioid use disorder; 3) evidence for opioid agonist treatment of pregnant women with opioid use disorder; and 4) implications for treatment of women with opioid use disorder and next steps for research and practice.

The current opioid epidemic has produced important differences by sex and gender with increased rates of use and overdose deaths in women. Significant mental health concerns for women include co-occurring psychiatric disorders and suicide. Expanding medication treatment for perinatal opioid use disorder is crucial. While effective treatments exist for opioid use disorder, they are often not accessible, and a minority of patients are treated.

Conclusions: The end to the opioid epidemic will require innovative multi-systemic solutions. There are significant practice gaps in preventing rising death rates among women by opioid overdose, treating co-occurring psychiatric disorders and pain, and treating perinatal women with opioid use disorder and their infants. Research on sex and gender differences, and the intersection with race/ethnicity and US region, is critically needed and should include treatment implementation studies to achieve wider access for women to effective prevention, early intervention, and treatment.

Abstract:

The “Women and Trauma” Study (WTS) conducted in the National Drug Abuse Treatment Clinical Trials Network (CTN-0015) resulted in research publications, presentations, and a train-the-trainer workshop to support dissemination efforts for skills-based trauma treatment in substance use community treatment. Twelve years after its completion, this paper aims to examine whether and how the WTS contributed to knowledge in the field of trauma and addictions and inspired community treatment programs (CTPs) to train staff to identify and provide trauma-related services.

This article presents findings from two different analyses that explored longer-term study impacts on treatment and dissemination: (1) a post-study site survey covering 4 domains from 4/7 programs that participated in delivering the WTS to evaluate their perceptions of study impact on their treatment community; and (2) an analysis of citations of its publications to determine impact on the scientific community.

Surveys from responding sites indicated that participation in the study significantly increased their agencies” awareness of the need to take a focused approach to treating trauma issues in this population. Specifically, these sites increased their commitment to using skills-based trauma treatment with the study’s target population of female patients with SUD and trauma histories, as well as expanding it to other groups affected by trauma. Citation analysis revealed that according to the Web of Science, as of August 2019, the number of citations of 24 CTN-0015 articles, ranged from 1 to 135 (Mean = 20, SD = 33; Median = 6). Four of the most influential are discussed.

Conclusions: This article provides original information about the contributions of the WTS study, demonstrating how the study contributed to serving women with trauma in community substance use treatment.

Related protocols: CTN-0015

Abstract:

Sex risk behaviors and substance use are intertwined. Many men continue to engage in high-risk sexual behaviors even when enrolled in substance use disorder (SUD) treatment. We hypothesized that changes in sex risk behaviors would coincide with changes in drug/alcohol use severity among men in SUD treatment. During an HIV risk-reduction trial, CTN-0018, men in methadone maintenance and outpatient drug-free treatment (N=359) completed assessments at baseline and six months after. Changes in sex risk and substance use severity were assessed using the Addiction Severity Index-Lite (ASI-Lite), controlling for treatment condition.

In multinomial logistic regressions, decreased alcohol severity was significantly associated with decreases in reported sex partners, and increased alcohol severity was significantly associated with increases in reported sex partners. Increasing drug use severity was significantly associated with maintaining and initiating sex with a high-risk partner, while decreasing alcohol use severity was significantly associated with discontinuing sex under the influence. However, changes in drug/alcohol use severity were not associated with changes in unprotected sex.

Conclusions: Substance use reductions may decrease HIV risk behaviors among male substance users. Our findings highlight the importance of integrating interventions in SUD treatment settings that address the intersection of sex risk behaviors and substance use.

Related protocols: CTN-0018

Abstract:

Sexual risk behavior is now the primary vector of HIV transmission among substance users in the United States with gender as a crucial moderator of risk behavior. This study examined gender differences in factors (age, race/ethnicity, education) that predict main-partner unprotected sexual occasions (USO) using the unique platform of two parallel NIDA Clinical Trials Network gender-specific safer sex intervention trials. Baseline assessments of male (N=430) and female (N=377) participants included demographic characteristics; past 3-month sexual activity; and a diagnostic assessment for alcohol, cocaine/stimulant, and opioid use disorders. Using mixed effects generalized linear modeling of the main outcome USO, two-way interactions of gender with age, race/ethnicity, and education were evaluated and adjusted by alcohol, cocaine/stimulant, or opioid use disorder.

When adjusted for alcohol use disorder, the interaction of education and gender was significant. For men, a high school or greater education was significantly associated with more USO compared to men with less than high school. For women, greater than high school education was significantly associated with less USO compared to women with a high school education. None of the other interactions were significant when adjusted for cocaine/stimulant or opioid use disorder.

Conclusions: This study demonstrates gender differences in the relationship of education, alcohol use disorder, and main-partner USO in individuals in substance abuse treatment. This underscores the importance of considering demographic and substance use factors in HIV sexual risk behavior and in crafting prevention messages for this population.

Related protocols: CTN-0018, CTN-0019

Abstract:

Receptive anal sex has high human immunodeficiency virus (HIV) transmission risk, and heterosexual substance-abusing individuals report higher anal sex rates compared to their counterparts in the general population. This secondary analysis of two NIDA Clinical Trials Network studies (CTN-0018 and CTN-0019) evaluated the effectiveness of two gender-specific, evidence-based HIV prevention interventions (Real Men are Safe, or REMAS, for men; Safer Sex Skill Building, or SSSB, for women) against an HIV education (HIV-Ed) control condition on decreasing unprotected heterosexual anal sex (HAS) among substance abuse treatment-seeking men (n=171) and women (n=105). Two variables, engagement in any HAS and engagement in unprotected HAS, were assessed at baseline and three months post-intervention.

Compared to the control group, women in the gender-specific intervention did not differ on rates of any HAS at follow-up but significantly decreased their rates of unprotected HAS. Men in both the gender-specific and the control interventions reported less HAS and unprotected HAS at three-month follow-up compared to baseline, with no treatment condition effect.

Conclusions: Women and men showed different patterns when it came to unprotected HAS. For men, rates of unprotected HAS decreased overall in the sample, and patterns suggest the reduction may, at least partly, reflect their decreased rates of engaging in any HAS. On the other hand, SSSB women did show a decrease in unprotected HAS compared to controls despite no significant difference in overall HAS rates. For them, the results suggest the SSSB intervention did produce intentional action toward risk reduction. The mechanism of action for SSSB compared to REMAS in decreasing unprotected HAS is unclear. More attention to HAS in HIV-prevention interventions for heterosexual men and women in substance abuse treatment is warranted.

Related protocols: CTN-0018, CTN-0019

Abstract:

HIV transmission often occurs through heterosexual high-risk sex. Even in the era of HIV combination prevention, promoting condom use and understanding barriers to consistent condom use remain priorities, especially among substance-dependent individuals.

This secondary analysis used data from CTN-0018 and CTN-0019, two NIDA Clinical Trials Network studies that compared a five-session gender-specific risk reduction group (Real Men Are Safe for men, Safer Sex Skills Building for women) to a one-session HIV Education Group for men and women (N=729) in outpatient drug treatment. Condom barriers (Motivation, Partner-Related, Access/Availability, Sexual Experience) were assessed at baseline and 6-month follow-up.

Intervention condition was not associated with condom barriers across any of the four domains; however, individuals who attended at least three of the five SSSB/REMAS sessions or the single session of HIV Education were more likely to report fewer motivation and partner-related barriers. Among women, reductions in motivation and sexual experience barriers were associated with less sexual risk with primary partners. For both men and women, reductions in partner-related barriers were associated with fewer unprotected vaginal/anal sex acts with primary partners.

Conclusions: Condom barriers are important to gender-specific HIV prevention; given limited resources, brief interventions maximizing active components are needed.

Related protocols: CTN-0018, CTN-0019

Abstract:

Despite advances toward integration of care for women with co-occurring substance use disorder (SUD) and post-traumatic stress disorder (PTSD), low abstinence rates following SUD/PTSD treatment remain the norm. The utility of investigating distinct substance use trajectories is a critical innovation in the detection and refining of effective interventions for this clinical population. The present study reanalyzed data from the largest randomized clinical trial to date for co-occurring SUD and PTSD in women (National Drug Abuse Treatment Clinical Trials Network protocol CTN-0015, “Women’s Treatment for Trauma and Substance Use Disorders”). Randomized participants (n=353) received one of two interventions in addition to treatment as usual for SUD: 1) trauma-informed integrative treatment for PTSD/SUD (Seeking Safety); or 2) an active control psychoeducation course on women’s health (Women’s Health Education).

The present study utilized latent growth mixture models (LGMM) with multiple groups to estimate women’s substance use patterns during the 12-month follow-up period. Findings provided support for three different trajectories of substance use in the post-treatment year: 1) consistently low likelihood and use frequency; 2) consistently high likelihood and use frequency; and 3) high likelihood and moderate use frequency. Covariate analyses revealed improvement in PTSD severity was associated with membership in a specific substance use trajectory, although receiving trauma-informed treatment was not. Additionally, SUD severity, age, and after-care efforts were shown to be related to trajectory membership.

Conclusions: Findings highlight the necessity of accounting for heterogeneity in post-treatment substance use, relevance of trauma-informed care in SUD recovery, and benefits of incorporating methodologies like LGMM when evaluating SUD treatment outcomes. For women dually diagnosed with PTSD and SUD, the current study established the presence of several varied clinical presentations linked to substance use following treatment, each with potentially different needs, vulnerabilities, and strengths. Results of this study also point to opportunities for tailing interventions to the specific clinical presentation and potential impact of these choices on a woman’s trajectory of recovery.

Abstract:

Although HIV prevention during substance abuse treatment is ideal, existing HIV risk-reduction interventions are less effective among Black and other ethnic minority substance abusers. The Sexual Health Model (SHM) and Person, Extended Family and Neighborhood-3 model (PEN-3) both highlight the importance of increasing our understanding of the relationship of sociocultural factors to sexual decision-making as a step towards developing more HIV prevention interventions for ethnic minorities. However, few studies examine sociocultural factors in the sexual decision-making process of Black substance abusing men. This secondary analysis of data collected in an evaluation of Real Men Are Safe (REMAS), an HIV prevention intervention, in the NIDA Clinical Trials Network (CTN) addressed this gap by examining the relation of two specific sociocultural factors (i.e., masculinity and perceived barriers to condom use) to the self-reported sexual behaviors of Black substance abusing men with their main and casual female partners.

Analyses of the baseline data of 126 Black men entering substance abuse treatment revealed that the endorsement of both personal and social masculinity predicted more unprotected sexual occasions (USO) with casual partners. The perception that condoms decreased sexual pleasure also predicted higher USO rates with casual partners. However, fewer partner barriers was not associated with USO among casual partners as expected. Neither the endorsement of social or personal masculinity or perceived condom barriers predicted USO with main partners.

Conclusions: These findings suggest that interventions that depict condom use as both pleasurable and congruent with Black male perceptions of masculinity may be more effective with Black substance abusing men than interventions focusing solely on health beliefs or education. Future research should continue to investigate the influence of other sociocultural factors, especially those that influence the sexual decision-making process, on sexual risk behaviors among Black men, as well as other groups.

Related protocols: CTN-0018

Abstract:

This secondary analysis of data from National Drug Abuse Institute Clinical Trials Network protocol CTN-0015, “Women’s Treatment for Trauma and Substance Use Disorders,” investigated the impact of 12 sessions of Seeking Safety (SS) on reducing posttraumatic stress disorder (PTSD) symptoms in a sample of dually diagnosed women with physical disabilities versus nondisabled (ND) women. SS is an evidence-based and widely implemented manualized therapy for PTSD and/or substance use disorder. It is a present-focused model that promotes coping skills and psychoeducation. In CTN-0015, 353 participants with current PTSD and substance use disorder (SUD) were randomly assigned to partial-dose SS or Women’s Health Education (WHE) group therapy conducted in a community-based substance abuse treatment program. The women were categorized as participants with disabilities (PWD; n=20) or ND (n=333) based on the question, “Do you receive a pension for a physical disability?” PTSD was assessed with the Clinician-Administered PTSD Scale (CAPS) at baseline and follow-ups after treatment (1 week, 3 months, 6 months, and 12 months). PWD experienced sustained reductions in PTSD symptoms when treated with SS but not WHE. Indeed, PTSD symptoms of PWD in WHE returned to baseline levels of severity by 12-month follow-up. This pattern of results was not observed among ND women, who sustained improvements on PTSD in both treatment conditions.

Conclusions: These results suggest strong potential for using Seeking Safety to treat PTSD among women with physical disabilities, an intervention that may be particularly relevant for this population by providing a trauma focus without requiring clients to delve into painful traumatic memories and instead offering a present and optimistic focus on coping skills and education. This is a vulnerable population for whom trauma is bound up closely with disability; the finding here, that women with disabilities had better outcomes in the Seeking Safety group than the Women’s Health Education group, speaks to the genuine need to address trauma and PTSD more directly in those with disabilities.

Related protocols: CTN-0015

Abstract:

Given high drop-out rates and difficulties with retention among women in treatment for co-occurring post-traumatic stress disorder (PTSD) and substance use disorders (SUD), research to determine the specific conditions under which this population can best be engaged and benefit from treatment is important. This study examined the relationship between racial/ethnic match and treatment outcomes for 224 women who participated in a National Drug Abuse Treatment Clinical Trials Network (CTN) study of group treatments for posttraumatic stress disorder (PTSD) and substance use disorders, “Women’s Treatment for Trauma and Substance Use Disorders” (CTN-0015). Generalized estimating equations were used to examine the effect of client-therapist racial/ethnic match on outcomes.

Results revealed racial/ethnic match was not significantly associated with session attendance. There was a significant three-way interaction between client race/ethnicity, baseline level of PTSD symptoms, and racial/ethnic match on PTSD outcomes. White clients, with severe PTSD symptoms at baseline, who attended treatment groups where they were matched with their therapist, had greater reductions in PTSD symptoms at follow-up than their counterparts who were racially/ethnically mismatched with their group therapist. Racial/ethnic match did not confer additional benefits for black clients in terms of PTSD outcomes. Racial/ethnic match interacted with baseline substance use to differentially influence substance use outcomes at follow-up for all women.

Conclusions: Overall, these findings revealed the complexity of racial/ethnic matching between client and therapist and its impact, particularly within a group treatment context. While racial/ethnic matching may provide, in some circumstances, a context that facilitates understanding, enhances trust, and strengthens the alliance; under other conditions, racial/ethnic matching may not confer additional benefits. These findings highlight the need for further examinations into individual and subgroup differences in the benefits of racial/ethnic matching.

Related protocols: CTN-0015

Abstract:

Individuals with substance use disorders are often plagued by psychiatric comorbidities and histories of physical and/or sexual trauma. Males and females, although different in their rates of expressed trauma and psychiatric symptomatology, experience comparable adverse consequences, including poorer substance abuse treatment outcomes, diminished psychosocial functioning, and severe employment problems. This study’s goal was to examine the relationships between trauma history, lifetime endorsement of psychiatric symptoms, and gender in a sample of individuals participating in outpatient substance abuse treatment.

Study participants (N=625) from six psychosocial counseling and five methadone maintenance programs were recruited as part of a larger study of an employment intervention conducted through the National Drug Abuse Treatment Clinical Trials Network (CTN-0020, “Job Seekers Training for Patients with Drug Dependence”). Measures included lifetime trauma experience (yes/no), type of trauma experienced (sexual, physical, both), lifetime depression/anxiety, and lifetime suicidal thoughts/attempts (as measured by the Addiction Severity Index-Lite (ASI-Lite)). Lifetime endorsement of psychiatric symptoms was compared between individuals with and without trauma history. The role of gender was also examined. Results indicated that the experience of trauma was associated with an increase in lifetime report of psychiatric symptoms. Experience of physical and combined physical and sexual trauma consistently predicted positive report of psychiatric symptoms in both males and females, even when controlling for demographic and treatment-related variables. Employment outcomes, however, were not predicted by self-reported history of lifetime trauma.

Conclusions: Consistent with previous research, a substantial proportion of the study sample — nearly 50% — reported a lifetime history of physical and/or sexual victimization. Also not surprisingly, the hypothesis regarding gender differences in rates of abuse was also confirmed in this study, a finding consistent with prior research demonstrating that women with SUDs typically experience dramatically higher rates (2 times or greater) of lifetime physical and sexual trauma than men. That said, although rates of trauma in the current sample were higher for women, the severity of mental health symptoms was comparable in males and females, suggesting that the aftermath of trauma equally affects both sexes. These findings highlight the need for improved gender-specific trauma screening and intervention strategies, as well as future research on techniques to better identify and treat the overlooked population of men with trauma histories.

Related protocols: CTN-0020

Abstract:

This CTN ancillary investigation aimed to examine predictors and moderators of response to two HIV sexual risk interventions of different content and duration for individuals in substance abuse treatment programs. Participants were recruited from community drug treatment programs participating in the National Drug Abuse Treatment Clinical Trials Network (CTN). Data were pooled from two parallel randomized controlled CTN studies, CTN-0018 and CTN-0019 (“Reducing HIV/STD Risk Behaviors: A Research Study for Men/Women in Drug Abuse Treatment”), each examining the impact of a multi-session HIV education intervention, on the degree of reduction in unprotected sex from baseline to 3- and 6-month follow-ups. The findings were analyzed using a zero-inflated negative binomial (ZINB) model.

Severity of drug use, gender, and age were significant main effect predictors of number of unprotected sexual occasions (USOs) at follow-up in the non-zero portion of the ZINB model (men, younger participants, and those with greater severity of drug/alcohol abuse have more USOs). Monogamous relationship status and race/ethnicity were significant predictors of having at least one USO vs. none (monogamous individuals and African Americans were more likely to have at least one USO). Significant moderators of intervention effectiveness included recent sex under the influence of drugs/alcohol, duration of abuse of the primary drug, and Hispanic ethnicity.

Conclusions: These predictor findings and moderator findings point to ways in which patients may be selected for the different HIV sexual risk reduction interventions and suggest potential avenues for further development of the interventions for increasing their effectiveness within certain subgroups, with particular attention to cultural sensitivity.

Related protocols: CTN-0018, CTN-0019

Abstract:

Sleep disruption appears not only to reflect a symptom of posttraumatic stress disorder (PTSD), but also a unique vulnerability for its development and maintenance. Studies examining the impact of psychosocial treatments for PTSD on sleep symptoms are few and no studies to date have examined this question in samples with co-occurring substance use disorders. This study is a secondary analysis of a large clinical trial comparing two psychological treatments for co-occurring PTSD and substance use disorders (National Drug Abuse Treatment Clinical Trials Network protocol CTN-0015, “Women’s Treatment for Trauma and Substance Use Disorders”). Women (n=353) completed measures of PTSD at baseline, end of treatment, and 3-, 6-, and 12-month follow-ups. Results indicated that the prevalence of insomnia, but not nightmares, decreased during treatment, and that 63.8% of participants reported at least 1 clinical-level sleep symptom at the end of treatment. Improvement in sleep symptoms during treatment was associated with better overall PTSD outcomes over time.

Conclusions: These results extend the existing literature to suggest that residual sleep disruption following PTSD treatment is common in women with co-occurring PTSD and substance use disorders. Although based on the design of the study, no causal conclusions can be drawn, the findings imply that among those with clinical-level residual sleep disruption, risk for continuation or exacerbation of overall PTSD symptoms may be higher. Consideration of the addition of interventions targeted to sleep disruption may be indicated in those with PTSD and SUD, or considered as an adjunctive intervention if residual sleep disruption is present at the time of treatment completion.

Related protocols: CTN-0015