Modafinil - Escitalopram Study for Cocaine Dependence
Condition: Cocaine Dependence; Cocaine Abuse; Cocaine Addiction; Substance Abuse
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to improve the efficacy of modafinil as a potential treatment
      for cocaine dependence.
    

Detailed description: 
      In this application, we propose an augmentation strategy intended to improve the efficacy of
      modafinil as a potential treatment for cocaine dependence. Recent data indicates that during
      chronic treatment modafinil produces substantial dopamine transporter (DAT) inhibition. Given
      that cocaine inhibits DA, norepenepherine (NE) and serotonin (5-HT) reuptake, it is highly
      likely that targeting more than one neurotransmitter system will be necessary for a
      medication to be effective. Assuming that this statement is true, we hypothesize that a
      combination pharmacotherapeutic approach that concurrently modulates multiple
      neurotransmitter systems will likely demonstrate a clinically significant level of efficacy
      above trials in which a single medication is used. The proposed approach is based on
      preclinical data indicating that medications that increase brain 5-HT levels reduce the
      effects of stimulants. We hypothesize that combining modafinil with a selective serotonin
      reuptake inhibitor (SSRI), which will increase synaptic levels of 5-HT, will further improve
      the efficacy of modafinil for reducing the effects produced by cocaine.

      Specific Aims: 1) to determine the effects of treatment with oral modafinil (0 or 200 mg)
      plus the SSRI escitalopram (0 or 20 mg) on the subjective and reinforcing effects produced by
      intravenous cocaine (0 and 20 mg) in the laboratory. 2) to characterize the cocaine dependent
      population and the genetic basis for the rewarding effects produced by cocaine. 3) to
      characterize the effect of both modafinil treatment and cocaine exposure onBrain Derived
      Neurotrophic Factor (BDNF) in plasma. We hypothesize that both modafinil treatment and
      cocaine exposure will alter plasma levels of BDNF. 4 a) provide a more frequent measure of
      heart rate (15 sec vs. 5 minutes) and b) measure a new dependent variable, physical activity,
      on days with and without cocaine exposure.
    

Intervention name(s): Modafinil and Escitalopram; Placebo; Modafinil; Escitalopram
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment 4: Modafinil 200 mg + Escitalopram 20 mg; Matching oral placebo capsules as control (Treatment 1: Modafinil 0 + Escitalopram 0).; Treatment 2: Modafinil 200 mg + Escitalopram 0.; Treatment 3: Modafinil 0 + Escitalopram 20 mg.
Other intervention name(s): Provigil; Lexapro; Sugar pill; Provigil; Lexapro
Intervention MeSH terms: Dexetimide; Modafinil; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Cocaine; Modafinil; Escitalopram