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Background: Patient-perceived Quality-of-Life (QOL) and treatment effectiveness (TEA) have previously been shown to be positively associated with better substance use treatment outcomes.
Objectives: This study examined potentially causal relationships amongst QOL, TEA, and cocaine abstinence.
Methods: Secondary data analyses (CTN-0148) were conducted on the NIDA Clinical Trial Network study, Cocaine Use Reduction with Buprenorphine (CTN-0048). N = 301 participants with DSM-IV cocaine dependence and opioid use history were administered injectable naltrexone and randomized to one of three buprenorphine/naloxone doses, 4 mg/1 mg, 16 mg/4 mg or placebo. Mediation models estimated direct and indirect effects amongst QOL, TEA, and cocaine abstinence.
Results: The QOL Environment domain exerted a significant indirect effect (B=0.01, SE=0.01, 95% CI=[0.00, 0.02]) on cocaine abstinence and a direct effect on TEA (B=0.57, SE=0.22, 95% CI=[0.16, 1.01]). Other QOL domains and individual QOL items exerted no statistically significant direct effects on cocaine abstinence. Overall QOL exerted a significant direct effect on TEA (95% CI=[0.32, 2.45]) along with a significant indirect effect on cocaine abstinence (95% CI=[0.01, 0.05]). TEA had a significant positive direct effect on cocaine abstinence (95% CI=[0.01, 0.02]).
Conclusion: Overall QOL and environmental QOL are related to treatment response through their relationship with patients’ perception of treatment effectiveness. TEA is directly related to cocaine abstinence at the end of treatment. QOL and TEA measures may serve as indicators of a need for additional support within care plans. These findings highlight the impact of a patient’s sense of well-being and their perceived treatment effectiveness on biochemically validated cocaine abstinence.
Related protocols: CTN-0148
Cocaine craving is a core symptom of cocaine use disorder (CUD) and remains a consistent obstacle to achieving sustained reductions in use and relapse prevention. A systematic review examining pharmacological treatment for cocaine craving reported that in their review of 130 clinical trials, there was an association between craving and multiple cocaine use outcomes in most studies, including both self-report and biochemical evidence of use (i.e., urinary benzoylecgonine). Some studies have examined relationships between craving and treatment efficacy with opioid agonists and shown more mixed results.
This study aimed to examine the relationship between self-reported cocaine craving over time (i.e., 100mm Visual Analog Scale) and cocaine use over time (measured via urine drug screen and self-report) in a sample of patients receiving medication treatment for cocaine use disorder (from CTN-0148).
Results from the urine drug screen model found that there was a significant relationship between cocaine craving and urine drug screens for cocaine use (OR=0.98, p<0.01), such that lower cocaine craving was associated with higher percentages of negative urine drug screens, while holding treatment assignment constant. Results from the self-reported use model found that there was a significant impact of time on self-reported cocaine use, and when examining the time by craving interaction (B=0.0008, p<0.01), such that lower cocaine craving was associated with higher percentages of negative self-reported cocaine use, while holding treatment assignment constant.
Conclusions: Low craving is significantly associated with decreased cocaine use over time while receiving placebo or buprenorphine and extended-release naltrexone. This therapeutic may represent a promising treatment to build on for the medical treatment for cocaine use disorder.
Related protocols: CTN-0148