Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      First, the investigators will determine whether Acceptance and Commitment Therapy in
      combination with Contingency Management increases initial treatment response rates.

      Second, for patients who do not respond to initial treatment, the investigators will examine
      whether dopamine-targeted pharmacotherapy is an effective augmentation strategy.

      Third, for patients who respond to initial treatment, the investigators will assess the
      relative benefit of continued treatment with Acceptance and Commitment Therapy in combination
      with Contingency Management, as compared to Drug Counseling in combination with Contingency
      Management, to prevent relapse.
    

Detailed description: 
      Drug addiction is a chronic, devastating, but treatable disorder, for which there exists a
      growing armamentarium of evidence-based interventions, including pharmacotherapies and
      psychotherapies. A core principle of drug addiction treatment, however, states that no single
      treatment is appropriate for everyone; rather, treatments need to be adjusted based on
      patient characteristics and response in order to be maximally effective. Ideally, clinicians
      would identify a sequence of interventions that works best across different stages of
      addiction treatment, from abstinence initiation to relapse prevention. Adaptive treatment
      interventions have been used successfully to inform this sequential clinical decision-making
      process. For cocaine use disorders (CUD), the most potent intervention currently available
      for initiating abstinence is behavior therapy using contingency management (CM) procedures.
      Intensive CM has been shown to produce initial cocaine abstinence rates of 40%, unmatched by
      all other forms of behavioral or pharmacological treatment, making it a prototypical
      first-line therapy for CUD. Importantly, achievement of initial abstinence predicts future
      abstinence. For the clinician, these research findings translate into a straightforward
      question: Can the investigators drive CM response rates even higher with targeted adjunctive
      interventions?

      The proposed sequential, multiple assignment, randomized trial (SMART) will provide the data
      needed to answer this question. First, the investigators will determine whether Acceptance
      and Commitment Therapy (ACT) in combination with CM increases initial treatment response
      rates. The investigators hypothesize that four weeks of treatment with ACT+CM will produce
      higher abstinence rates than initial treatment combining standard Drug Counseling with CM
      (DC+CM). The hypothesized synergism of ACT+CM on primary treatment mechanisms of experiential
      avoidance and reward sensitivity, respectively, will be examined. Second, for patients who do
      not respond to initial treatment, the investigators will examine whether dopamine-targeted
      pharmacotherapy is an effective augmentation strategy. Specifically, the investigators
      hypothesize that continued ACT+CM treatment with modafinil augmentation will be most
      effective in promoting abstinence relative to treatment combinations involving continued DC
      and/or placebo. Third, for patients who respond to initial treatment, the investigators will
      assess the relative benefit of continued treatment with ACT+CM, as compared to DC+CM, to
      prevent relapse. ACT emphasizes goal-directed actions based on values that are intrinsically
      motivating, and is thereby expected to be a more effective intervention for extending the
      duration of abstinence following initial treatment with intensive CM.
    

Intervention name(s): Acceptance and Commitment Therapy (ACT); Drug Counseling (DC); Contingency Management (CM); Placebo; Modafinil
Intervention type(s): Behavioral; Behavioral; Behavioral; Drug; Drug
Intervention description(s): ACT will assist cocaine patients to notice internal cravings and triggers, abandon attempts to manage these triggers via active avoidance, suppression or other control-based strategies, and to make commitments to engage in behaviors consistent with chosen values or goals. ACT encourages clients to experience thoughts and feelings from an observer perspective, and helps clients not to believe distressing thoughts and feelings as if those thoughts and feelings are literally true and in need of action. ACT treatment will be based on the ACT therapy manual developed and tested previously.; The investigators will use the manual-guided individual DC modeled after the NIDA Collaborative Cocaine Treatment Study and used as the active control therapy in previous studies. DC approximates clinical practice as it is considered the most common type of evidence-based treatment in the community for patients actively using cocaine.; The investigators will use the same high-magnitude CM schedule shown previously to be feasible and effective in facilitating initial cocaine abstinence. Subjects will earn vouchers for cocaine-negative urine samples collected at scheduled clinic visits each week. Under an escalating reinforcement schedule, voucher values will begin at $15 and increase by $10 for each consecutive negative urine. Bonus vouchers of $10 will be given for three consecutive negative urines. Provision of a cocaine-positive urine or failure to provide a scheduled sample will result in no vouchers earned and will reset the schedule to the initial value of $15.; The placebo capsule will be filled with corn starch and riboflavin.; Modafinil capsules will start at 200 mg (day 1) and increase to the fixed dose of 300 mg (day 2) and will also contain riboflavin.
Other intervention name(s): ACT; DC; CM; Corn Starch; Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment