Clinical Trial: Aripiprazole to Reduce Cocaine Relapse

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preventing Cocaine Relapse: Developing Pharmacotherapies

Brief Summary: Despite the many behavioral and cognitive treatment therapies that exist for cocaine addiction, individuals who complete cocaine abuse treatment are still at high risk for relapsing. Aripiprazole, a medication that is currently used to treat schizophrenia, may be useful in preventing drug relapse in individuals addicted to cocaine. This three-part study will evaluate the interaction between aripiprazole and cocaine. It will also determine the safety and effectiveness of aripiprazole in preventing drug relapse among cocaine addicts.

Detailed Summary:

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Cocaine abusers often report that upon attempting to demonstrate control over the drug by only "sampling" it following a period of abstinence, they are more likely to relapse. These small "sampling" amounts of cocaine are thought to function as priming doses. Priming doses act as a stimulus in the brain to signal that there is more cocaine available, which in turn may lead to further cocaine use. Medications that reduce the stimulating effect of the cocaine priming dose may be useful in preventing cocaine relapse. Aripiprazole, a medication that is currently used to treat schizophrenia, may be effective at reducing relapse in individuals addicted to cocaine. By enhancing activity of the brain chemicals dopamine and serotonin, aripiprazole may counter the effects of cocaine and also reduce cocaine cravings.

This study will involve three sequential experiments. Experiment 1 will evaluate the physiological and behavioral effects of various combinations of cocaine and aripiprazole. Experiment 2 will evaluate the capability of aripiprazole at reducing the stimulating effects of cocaine. Lastly, Experiment 3 will evaluate the role of cocaine priming doses on subsequent cocaine use and how aripiprazole might alter the effect of the priming dose. In turn, these findings may lead to future clinical trials using aripiprazole to treat cocaine addiction and prevent relapse.

All three experiments will involve inpatient hospital stays. Participants will be required to refrain from using any non-study drugs, other than nicotine, and will undergo daily urine and breathalyzer tests. Questionnaires will be used to assess drug effects and cocaine cravings, and a computerized test will measure motor function and perfor
Sponsor: Craig Rush

Current Primary Outcome: Behavioral effects of cocaine [ Time Frame: Measured throughout the study ]

Original Primary Outcome:

  • Experiment 1:
  • Safety and tolerability of cocaine and aripiprazole (measured by Adjective-Rating Scale, Cocaine-Craving Questionnaire, Drug-Effect Questionnaire, and Stimulant-Sensitive Adjective-Rating Scale throughout the study)
  • Experiment 2:
  • Percentage of cocaine-appropriate responses and monetary reward experiment results (measured at Days 53-57)
  • Experiment 3:
  • Monetary reward experiment results (measured throughout the study)


Current Secondary Outcome: Heart rate; blood pressure; ECG [ Time Frame: Measured throughout the study ]

Original Secondary Outcome:

  • Experiments 1, 2, and 3:
  • Subjective effects of cocaine (measured by Adjective-Rating Scale, Cocaine-Craving Questionnaire, Drug-Effect Questionnaire, and Stimulant-Sensitive Adjective-Rating Scale throughout the study)
  • Psychomotor function (measured by Digit-Symbol-Substitution Test throughout the study)
  • Heart symptoms (measured by blood pressure and ECG throughout the study)


Information By: University of Kentucky

Dates:
Date Received: January 11, 2006
Date Started: January 2006
Date Completion:
Last Updated: April 5, 2017
Last Verified: April 2017