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This booklet contains an overview of the National Drug Abuse Treatment Clinical Trials Network, along with a description of each participating Node.
Provides an overview of clinical trials, what they are and how they work, and then answers some commonly posed questions from participants wondering “Should I participate?” or “What questions should I ask?”
Several large-scale, pragmatic clinical trials on opioid use disorder (OUD) have been completed in the National Drug Abuse Treatment Clinical Trials Network (CTN). However, the resulting data have not been harmonized between the studies to compare the patient characteristics. This paper provides lessons learned from a large-scale harmonization process that are critical for all biomedical researchers collecting new data and those tasked with combining datasets.
Researchers harmonized data from multiple domains from CTN-0027 (N = 1269), which compared methadone and buprenorphine at federally licensed methadone treatment programs; CTN-0030 (N = 653), which recruited patients who used predominantly prescription opioids and were treated with buprenorphine; and CTN-0051 (N = 570), which compared buprenorphine and extended-release naltrexone (XR-NTX) and recruited from inpatient treatment facilities. Patient-level data were harmonized and a total of 23 database tables, with meticulous documentation, covering more than 110 variables, along with three tables with “meta-data” about the study design and treatment arms, were created. Domains included: social and demographic characteristics, medical and psychiatric history, self-reported drug use details and urine drug screening results, withdrawal, and treatment drug details.
In this paper, the authors summarize the numerous issues with the organization and fidelity of the publicly available data which were noted and resolved, and present results on patient characteristics across the three trials and the harmonized domains, respectively. A systematic harmonization of OUD clinical trial data can be accomplished, despite heterogeneous data coding and classification procedures, by standardizing commonly assessed characteristics. Similar methods, embracing database normalization and/or “tidy” data, should be used for future datasets in other substance use disorder clinical trials.
Related protocols: CTN-0027, CTN-0030, CTN-0051
This study sought to understand participants’ perceptions of their assigned treatment in a randomized control trial examining the use of extended-release naltrexone versus treatment as usual for substance use disorders. Researchers administered semi-structured interviews among 22 prospective and actual participants in a larger clinical trial examining the feasibility of extended-release naltrexone for both opioid and alcohol use disorders among people living with HIV. Interviews were transcribed, coded, and analyzed thematically.
Participants described their study experience as mostly positive, but also concurrently held or developed study medication apprehensions and misperceptions. First, some participants described apprehension, lack of control, and uneasiness regarding their assigned treatment. Second, some participants perceived their treatment as “placebos” and/or were convinced that their treatment was ineffective, shaping perceptions of impact on their substance use. Third, some participants perceived study treatments as cure-alls for substance use disorders.
Conclusions: Participant perceptions of trial interventions may frame their experience and participation in clinical studies. These findings demonstrate the need for researchers and clinicians to consider how apprehension and a lack of medication receptivity may impact enrollment and participant autonomy. They also identify opportunities for greater community engagement in trial design and implementation in order to improve participant education about the nature of interventions and the potential of ongoing consent processes integrated throughout studies to promote participant understandings of study purposes and objectives.
Related protocols: CTN-0055
High retention rates are critical for successful clinical trials, but participants in clinical research on stimulant abuse have demonstrated variable attendance at intervention and research visits. This poster reports on an innovative recruitment technique used by study staff in the National Drug Abuse Treatment Clinical Trials Network protocol CTN-0037 (Stimulant Reduction Intervention Using Dose Exercise (STRIDE)) to address some of the reasons for decreased attendance and barriers to retention before they become an issue for study participants. Nicknamed the “Fireside Chat,” the STRIDE approach used a series of “warm, supportive” questions to open a conversation with potential study participants, with the aim of helping them make an informed decision in a relatively short amount of time whether or not to join the study. Questions in the “chat” focused on willingness to commit, importance of the research question to the participant, understanding the requirements of participation, specific barriers to attendance, clarification of the study interventions/condition preference, and relapse potential.
Anecdotally, one site noted retention improvements after the Fireside Chat was implemented, and participants often expressed appreciation for taking part in the Chat. Though improvements cannot be solely attributed to the technique, research team members reported that being able to refer back to the Fireside Chat with participants helped them more openly discuss barriers to continued study participation. Clinical research with ongoing participant contact should consider tailoring this approach to increase retention. Future investigation with this approach is advised.
Related protocols: CTN-0037
This brochure, intended for participants thinking about joining the CTN-0044 clinical trial (Web Delivery of Evidence-Based, Psychosocial Treatment for Substance Use Disorders), describes a web-based program called Therapeutic Education System (TES) and how it can be used to help people get off and stay off drugs. Common questions participants might have are answered, including questions about compensation, what to expect from the study, and who can join.
Related protocols: CTN-0044
This brochure, intended for participants thinking about joining the CTN-0037 clinical trial (Stimulant Reduction Intervention Using Dosed Exercise), describes the aims of the study, which seeks to find out whether exercise can help people get off and stay off drugs, and what participants can expect after they sign up.
Related protocols: CTN-0037
This brochure, intended for participants thinking about joining the CTN-0046 (Smoking Cessation and Stimulant Treatment Study (S-CAST)) protocol, provides an overview of the project and answers any questions participants might have. This study will compare participating clinics’ treatment as usual for stimulant dependence with a combination of treatment for stimulant dependence and smoking cessation to discover the latter’s impact on stimulant-use outcomes, outcomes for other drugs of abuse, and smoking outcomes. Research shows that rates of smoking in cocaine and methamphetamine users are 3-4 times greater than in the general population; it is hoped that this combined approach will be effective for reducing both smoking and stimulant use in participants.
Related protocols: CTN-0046
This brochure, intended for participants thinking about joining the CTN-0031 protocol (Stimulant Abuser Groups to Engage in 12-Step (STAGE-12): Evaluation of a Combined Individual-Group Intervention to Reduce Stimulant and Other Drug Use by Increasing 12-Step Involvements) provides an overview of the project and answers any questions participants might have.
This study will evaluate the degree to which a combined group and individual intervention that also uses recovery mentors improves substance-related outcomes compared to treatment as usual.
Related protocols: CTN-0031
This brochure, intended for participants thinking about joining the CTN-0027 clinical trial (Starting Treatment with Agonist Replacement Therapies), answers questions about who can participate and what happens if you join, and provides information about the medication used in the project, buprenorphine naloxone (Suboxone).
Related protocols: CTN-0027
This brochure, intended for participants thinking about joining the CTN-0030 (Prescription Opioid Addiction Treatment Study (POATS)) protocol, provides an overview of the project and answers any questions participants might have. The main objective of this trial is to identify effective treatment regimen for sublingual Buprenorphine/Naloxone (BUP/NX) in patients dependent on prescription opioids. The first phase will assess the currently prevailing 1-month detoxification practice. The second phase will compare the effectiveness of standard medical (BUP/NX) management and medical management (BUP/NX) enhanced by intensive individual drug counseling (IDC) in those patients that were not successful in the previous phase.
Related protocols: CTN-0030
This brochure, intended for participants thinking about joining the CTN-0017 clinical trial (HIV and HCV Intervention in Drug Treatment Settings), provides an overview of the study’s aims, a description of what participation will involve, and information about compensation.
Related protocols: CTN-0017
This brochure, intended for teenagers thinking about joining the CTN-0028 (Osmotic-Release Methylphenidate for ADHD in Adolescents with Substance Use Disorders) study, provides an overview of the project and answers any questions participants might have.
Related protocols: CTN-0028
This brochure, intended for participants thinking about joining the CTN-0004 (MET to Improve Treatment Engagement and Outcome in Subjects Seeking Treatment for Substance Abuse) or CTN-0021 (Motivational Enhancement Treatment to Improve Treatment Engagement and Outcomes for Spanish-Speaking Individuals Seeking Treatment for Substance Abuse) studies, provides an overview of MET and answers any questions participants might have about being involved in the research project.
Related protocols: CTN-0004, CTN-0021
This brochure, intended for participants in the CTN-0009 (Smoking Cessation Treatment with Transdermal Nicotine Replacement Therapy in Substance Abuse Rehabilitation Programs) study, provides an overview of what the project will entail and answers any questions participants might have.
Related protocols: CTN-0009