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Aripiprazole to Reduce Cocaine Relapse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00276874
Recruitment Status : Completed
First Posted : January 13, 2006
Last Update Posted : April 6, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Craig Rush, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Cocaine-Related Disorders Drug: Aripiprazole Drug: Placebos Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preventing Cocaine Relapse: Developing Pharmacotherapies
Study Start Date : January 2006
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aripiprazole
Subjects receive oral aripiprazole.
Drug: Aripiprazole
Aripiprazole; 0-30 mg; oral; daily
Other Name: Abilify

Placebo Comparator: Placebo
Subjects receive oral placebo
Drug: Placebos
Placebo; 0 mg; oral; daily

Primary Outcome Measures :
  1. Behavioral effects of cocaine [ Time Frame: Measured throughout the study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00276874

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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
Craig Rush
National Institute on Drug Abuse (NIDA)
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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

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Responsible Party: Craig Rush, Principal Investigator, University of Kentucky Identifier: NCT00276874    
Other Study ID Numbers: DA020429
R01DA020429 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2006    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: April 2017
Keywords provided by Craig Rush, University of Kentucky:
Cocaine Addiction
Cocaine Dependence
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists