Effects of Aripiprazole on Cocaine Craving and Self-Administration

NCT ID: NCT00373880

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2008-09-30

Brief Summary

The purpose of this study is to investigate whether aripiprazole will decrease cocaine self-administration, subjective effects and cravings compared to placebo.

Detailed Description

Despite the recent increase in data about cocaine's basic neurochemical mechanisms of action, progress towards the development of an effective pharmacological treatment for cocaine abuse has been disappointing. We are proposing to use our laboratory model of repeated dose cocaine self-administration to assess the potential efficacy of the novel antipsychotic, aripiprazole. Aripiprazole is a partial agonist at both the dopamine D2 receptor and at the serotonin 5HT1a receptor, while antagonizing the 5HT2a receptor. By functioning as a partial D2 agonist, aripiprazole is hypothesized to function as a D2 antagonist during hypodopaminergic states, such as during cocaine use, while functioning as a D2 agonist during hypodopaminergic states, such as during cocaine withdrawal. This 42-day, outpatient/inpatient/outpatient/inpatient protocol will evaluate the effects of aripiprazole maintenance (0, 15 mg/day) on cocaine craving, subjective effects, and self-administration using a within-subjects design. Non-treatment seeking cocaine abusers will be maintained outpatient for 16 days of dose maintenance prior to inpatient cocaine self-administration sessions. During the inpatient phases, volunteers will live on a hospital clinical research unit and will participate in laboratory sessions in which they will have the opportunity to choose between repeated doses of smoked cocaine and $5. In addition to measuring their cocaine self-administration, we will measure the cardiovascular and subjective effects of cocaine under each aripiprazole maintenance condition.

Conditions

Cocaine Abuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Aripiprazole (15mg) + Cocaine

Aripiprazole (15 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg).

Group Type: EXPERIMENTAL

Aripiprazole + Cocaine

Intervention Type: DRUG

Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).

Placebo + Cocaine

Placebo (0 mg/day) in conjunction with a smoked cocaine dose-response curve (0, 12, 25, 50 mg)

Group Type: PLACEBO_COMPARATOR

Placebo + Cocaine

Intervention Type: DRUG

Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).

Interventions

Aripiprazole + Cocaine

Participants received aripiprazole (15mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).

Intervention Type: DRUG

Placebo + Cocaine

Placebo (0 mg/day) in conjunction with a dose-response of cocaine (0, 12, 25, 50 mg).

Intervention Type: DRUG

Other Intervention Names

Active; Placebo

Eligibility Criteria

Inclusion Criteria

• Meets DSM-IV criteria for current cocaine abuse
• Average use of smoked cocaine is at least 2x/week for past 6 mos); currently spends at least $70 per week on cocaine
• Has patterns of smoked cocaine use in terms of frequency and amounts which parallel or exceed those administered in the study
• Age 21-45
• Able to give informed consent, and comply with study procedures

Exclusion Criteria

• Current seizure disorder, heart disease or psychiatric disorders (other than cocaine dependence)
• Dependence on substances other than cocaine or nicotine
• Request for drug treatment
• Judged to be noncompliant with study protocol
• Current use of any medication that has the potential to interact with aripiprazole (i.e., seizure medications, anti-fungal medications, cardiac medications, or medication that produces drowsiness)
• Clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; BUN, creatinine, LFTs > 1.5 ULN; hematocrit < 34 for women, < 36 for men; pseudocholinesterase deficiency)
• Currently meeting DSM-IV criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse
• Current parole or probation
• History of significant violent or suicidal behavior

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Haney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

Irving Center for Clinical Research

New York, New York, United States

Countries

United States

Other Identifiers

4741

Identifier Type: -

Identifier Source: org_study_id