This is a competing renewal of our 2x2 study evaluating methadone vs. buprenorphine and the Community Reinforcement Approach (CRA) with and without Contingency Management (CM) for the treatment of patients with concurrent opioid and cocaine dependence. Data analyses showed significantly greater improvements for methadone vs. buprenorphine and limited efficacy of CM, with a rebound in drug use after the value of the vouchers was reduced to a nominal level. Limitations of CRA and CM with opiate agonist maintained patients identified in this and other studies include the low motivation of patients to address problems of cocaine use; difficulties implementing the multifaceted and complex treatment; and the limited efficacy of CM. Therefore, we are proposing a Stage I study for manual development and pilot testing of a behavioral and social-learning theory based treatment for agonist maintained patients with combined opioid and cocaine dependence that addresses several weaknesses of CRA and CM in this population. This treatment, referred to as Therapeutic Contracting (TC), combines core aspects of the Community Reinforcement Approach (CRA) associated with improved outcome in the current study and cognitive and social learning theory based techniques which can serve as alternatives to CM for enhancing patients motivation, overcoming demoralization, and improving goal achievement. In the proposed study, we plan first to refine TC and develop an individual therapy manual and training materials for it during pre-pilot testing in 10 methadone maintained patients with combined opioid and cocaine dependence. During the pre-pilot, we also plan to develop TC adherence and competence rating scales. Subsequently, we plan to conduct a pilot study using a dismantling design to compare TC and one of its components, manual-guided cognitive-behavioral coping skills therapy (CBT). For the pilot, 3-5 therapists will be trained to administer each of the treatments and patients will be randomly assigned to 24 weeks of either TC or CBT. Primary outcome measures include reductions in illicit opioid and cocaine use and achievement of abstinence from them, as assessed by three times per week urine toxicology tests and self-report. The pilot study will be used to estimate the potential effect size of the difference between these two treatments and to evaluate the feasibility of comparing TC and CBT in a larger Stage II study. Feasibility will be evaluated by assessing whether therapists can be trained to adhere to the manuals and administer the treatments competently; whether patients can be retained in the treatments; and whether the treatments can be reliably discriminated by raters blinded to treatment assignment.
