A Sequenced Behavioral and Medication Intervention for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will investigate a treatment strategy in which a computer-assisted behavioral
      intervention will be used to help individuals stop their use of cocaine. A medication will be
      combined with the behavioral treatment among those individuals who do not respond to the
      behavioral intervention alone. The primary hypothesis of the study is that among cocaine
      dependent individuals who fail to respond to an initial trial of behavioral therapy, a
      greater proportion of individuals will benefit from the combined treatment (behavior therapy
      plus medication) compared to individuals in the comparison group.
    

Detailed description: 
      Cocaine Dependence is associated with substantial social, physical, and neurobiological
      problems. Psychosocial treatments can be helpful for many individuals. However, a significant
      proportion of individuals do not benefit from counseling alone. Our research group has
      demonstrated that deficient dopamine transmission, predicts poor response to a behavioral
      treatment and that a regiment that included an agonist replacement strategy with stimulants
      maybe effective for promoting abstinence in severe cocaine dependent patients.

      In this 15-week study 145 treatment-seeking cocaine dependent participants will receive a
      computer-assisted behavioral intervention based on the community reinforcement approach with
      contingency management (CRA + CM). The counseling approach will include both
      computer-assisted life skills training via and counseling. Individuals who fail to achieve
      abstinence will continue the behavioral treatment (CRA + CM) and will be randomly assigned to
      a behavioral therapy enhancement strategy that will include either Mixed Amphetamine
      Salts-Extended Release (80mg) or placebo.
    

Intervention name(s): Computer-assisted behavior therapy; Mixed-Amphetamine Salts- Extended Release (MAS-ER); Placebo
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.; 80 mg/day of Mixed-Amphetamine Salts- Extended Release (MAS-ER) and computer -assisted CBT; Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
Other intervention name(s): Therapeutic Educational System (TES); Adderall XR; Computer-assisted CBT, TES
Intervention MeSH terms: Amphetamine; Adderall
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Following an initial 4 week period where participants received computer-assisted behavioral intervention based on the community reinforcement approach with contingency management (CRA + CM), individuals who failed to achieve abstinence will continue the behavioral treatment (CRA + CM) and will be randomly assigned, in parallel, to a behavioral therapy enhancement strategy that will include either Mixed Amphetamine Salts-Extended Release (80mg) or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine Dependence Treatment; Computer-assisted therapy; Pharmacotherapy