Project: Research project

Project Details


This project assesses the safety and efficacy of pharmacological
treatments of cocaine and opioid abuse in clinical trials. Findings of
a clinical trial recently completed in our section do not support the
utility of carbamazepine in the treatment of cocaine dependence. A
double-blind, placebo-controlled clinical trial was completed testing
carbamazepine in cocaine dependent subjects. Outcome measures were
persent cocaine-negative urine samples, self-reported drug use, and self-
reported craving for cocaine. There were no significant differences
between subjects randomly assigned to the placebo or carbamazepine
treatment groups on any of the primary outcome measures. The
administration of carbamazepine to cocaine dependent individuals was safe
at the dose tested. Evidence from preclinical studies suggests that the reinforcing effects
of cocaine are related to its inhibition of dopamine reuptake. Much of
the work to develop pharmacological treatments of cocaine dependence has
thus far focused on dopaminergic agents, though no dopaminergic agents
have yet been shown to be effective in reducing cocaine use. An open
trial testing the safety and efficacy of combination treatment with
buproprion and bromocriptine, agents with dopaminergic activity, is
underway and has so far shown a low incidence of side effects among
treated subjects. This study is the first to apply the strategy of
combining pharmacologic agents to increase the efficacy of individual
agents in the treatment of cocaine dependence. The partial opiate agonist buprenorphine is a safe and effective
treatment for opiate dependence. Some preclinical studies and
uncontrolled clinical case series have suggested that buprenorphine might
also be effective in reducing cocaine use by opiate addicts. A double-
blind, controlled clinical trial is underway that directly evaluates the
efficacy of buprenorphine in reducing both opiate and cocaine use in
dually opiate- and cocaine-dependent patients. Medically supervised withdrawal from opioids is a commonly used treatment
but is usually not effective in establishing long-term abstinence because
patients frequently relapse soon after completion of the withdrawal. A
procedure for initiating naltrexone maintenance during withdrawal
treatment is being developed to provide a more effective post-withdrawal
treatment. The efficacy of buprenorphine/naltrexone combinations are
being tested in a clinical trial.
Effective start/end date8/5/957/31/01


  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health
  • National Institutes of Health: $109,218.00

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