- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00276874
Aripiprazole to Reduce Cocaine Relapse
Preventing Cocaine Relapse: Developing Pharmacotherapies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 performance. Heart rate and blood pressure will be monitored periodically; an electrocardiogram (ECG) will record continuously to monitor heart electrical activity. Following the end of each experiment, all participants will be offered a referral to a drug abuse treatment program.
The first experiment will last 9 weeks and will enroll 8 individuals addicted to cocaine. Participants will take part in daily sessions in which they will receive varying doses of cocaine and aripiprazole, alone and in combination. This will provide important information regarding the safety and tolerability of cocaine-aripiprazole combinations.
The second experiment will last 10 weeks and will enroll 12 individuals addicted to cocaine. Participants will take part in various phases, which will each last several days. The phases will include a cocaine sampling phase; a cocaine acquisition phase in which participants will receive monetary rewards for distinguishing between cocaine and placebo; a placebo phase; an aripiprazole maintenance phase; a cocaine dose response phase in which the ability of aripiprazole to reduce cocaine's stimulating effects will be examined; and a washout phase in which no drugs will be given. Cocaine and aripiprazole doses will be determined by the results of the first experiment.
The third experiment will last 8 weeks and will enroll 12 individuals addicted to cocaine. A self-administration procedure designed to model relapse will be used to assess the effects of priming doses of cocaine on subsequent cocaine-taking behavior, alone and following aripiprazole treatment. Participants will be assigned to receive placebo for the first part of the study followed by aripiprazole for the remainder of the study or vice versa. During experimental sessions, participants will receive a specified amount of cocaine, which will act as the priming dose. Next, participants will choose between receiving either another similar dose of cocaine or money. This will be followed by a washout phase and then several more sampling-choice sessions with differing amounts of cocaine. Cocaine and aripiprazole doses will be determined by the results of the first experiment.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40506
- University of Kentucky
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Meets DSM-IV diagnostic criteria for cocaine dependence
- Current cocaine use at study entry, as determined by a urine screen
- Body Mass Index of less than 30
- ECG results within normal limits
- If female, willing to use contraception throughout the study
Exclusion Criteria:
- Meets DSM-IV diagnostic criteria for dependence on any drugs other than cocaine or nicotine
- Currently seeking treatment for substance abuse
- Current or past serious illness, including impaired heart function, seizures, head trauma, or central nervous system tumors
- A family history of heart disease or seizures
- Current or past psychiatric disorder, other than substance abuse
- Pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aripiprazole
Subjects receive oral aripiprazole.
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Aripiprazole; 0-30 mg; oral; daily
Other Names:
|
Placebo Comparator: Placebo
Subjects receive oral placebo
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Placebo; 0 mg; oral; daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Behavioral effects of cocaine
Time Frame: Measured throughout the study
|
Measured throughout the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Heart rate; blood pressure; ECG
Time Frame: Measured throughout the study
|
Measured throughout the study
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Craig R. Rush, PhD, University of Kentucky
- Principal Investigator: Paul E Glaser, MD, PhD, University of Kentucky
- Principal Investigator: Lon R. Hays, MD, University of Kentucky
- Principal Investigator: Joshua A. Lile, PhD, University of Kentucky
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Cocaine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- DA020429
- DPMC (Other Identifier: NIDA)
- R01DA020429 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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