A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test whether a cognitive behavioral therapy (CBT) and a
      medication called modafinil, which is approved to treat sleep disorders, will help
      individuals who are abusing cocaine.
    

Detailed description: 
      Chronic cocaine abuse has been documented to produce cognitive impairments in various
      domains. The observed cognitive deficits in the substance abuse population include, but are
      not restricted to, attention, concentration, verbal and nonverbal memory, problem solving and
      abstract reasoning. Our recent studies (IRB Protocol # 3998) demonstrated that in cocaine
      dependent participants such cognitive deficits have been shown to: 1) negatively effect
      retention and 2) impede the ability of the drug abuser to benefit from cognitive behavioral
      therapy- relapse prevention (CBT-RP) that requires participant to attend to novel stimuli,
      integrate new information with existing stores, and translate information into behavior
      change (Aharonovich, Hasin & Nunes, 2003; Aharonovich et al, in press). Furthermore, the
      toxic effects of cocaine together with withdrawal symptoms, such as fatigue and hypersomnia
      make it difficult to fully engage in any psychosocial intervention including CBT-RP.

      Recent findings indicate that cocaine dysregulates reward-related glutamate pathways (Dackis
      & O'Brien, 2003; Kalivas et al, 2003). Modafinil is a medication known to improve attention,
      increase wakefulness, energy, and alertness in part by increasing glutamate levels. In light
      of this work and the negative affect of cognitive impairments on treatment outcomes, testing
      cognitive enhancing medications that act on glutamate pathways is a novel promising strategy
      for improving treatment for cocaine dependence. Modafinil is approved for sleep disorders and
      is a relatively safe medication for cocaine-dependent participants as it has a low abuse
      potential and has shown promise in a double blind placebo controlled trial for cocaine
      dependence (Rush et al, 2002; Jasinski, 2000, Dackis et al, 2005). We therefore propose a
      double blind placebo controlled 12-week exploratory pilot study of modafinil, a "wakefulness
      agent," in conjunction with sessions of CBT-RP enhanced with motivational interviewing
      components.
    

Intervention name(s): Modafinil; Cognitive Behavioral Therapy--Relapse Prevention
Intervention type(s): Drug; Behavioral
Intervention description(s): During the first lead-in week, participants will attend the clinic 3 times per week, participate in one session of neuropsychological assessment and receive motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP). At the end of the first lead-in week participants will be randomized to modafinil or placebo stratified by the levels of cocaine use, and whether or not abstinence was achieved. Participants will then be followed for 11 weeks with measures of cocaine cravings and withdrawal, and drug use outcome, and will receive CBT-RP.; Once weekly individual session of motivational interviewing and Cognitive Behavioral Therapy--Relapse Prevention (CBT-RP)
Other intervention name(s): Provigil; CBT-RP
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment