Effects of Aripiprazole on Cocaine Craving and Self-Administration

NCT00373880 | Completed Phase 2 Results

• 1 other identifier: 4741
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cocaine Abuse

Keywords

Aripiprazole; Cocaine abuse

Outcome Measures

Primary Outcomes (1)

• Cocaine Self-administration

  Mean number of cocaine choices as a function of cocaine dose and aripiprazole dose (n=8). Participants sampled the dose of cocaine available for the session and then had five choices to respond for money ($5.00) or cocaine using a modified progressive-ratio schedule.

  5 days

Secondary Outcomes (2)

• Subjective Effects of Cocaine

  5 days

• Plasma Cocaine

  8 minutes

Study Arms (2)

Aripiprazole (15mg) + Cocaine

EXPERIMENTAL

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

Drug: Aripiprazole + Cocaine

Placebo + Cocaine

PLACEBO COMPARATOR

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

Drug: Placebo + Cocaine

Interventions

Aripiprazole + Cocaine DRUG

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

Also known as: Active

Aripiprazole (15mg) + Cocaine

Placebo + Cocaine DRUG

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

Also known as: Placebo

Placebo + Cocaine

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Irving Center for Clinical Research

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Aripiprazole; Cocaine; Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

The study did not assess whether the medication would be useful in preventing relapse in abstinent cocaine users or whether aripiprazole would be beneficial to cocaine-dependent individuals being treated for a psychiatric comorbidity.

Results Point of Contact

• Title: Margaret Haney, Ph.D.
• Organization: New York State Psychiatric Institute at Columbia University Medical Center

meg.haney@nyspi.columbia.edu

646-774-6153

Study Officials

• Margaret Haney, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In order to achieve steady-state concentrations, participants (n=8 men) were administered placebo and aripiprazole (15 mg/day) capsules in counter-balanced order for 21 days. A smoked cocaine dose-response curve (0, 12, 25, 50 mg) was determined twice under placebo and aripiprazole maintenance.

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: April 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: September 1, 2008
• Last Updated: September 11, 2017
• Results First Posted: September 11, 2017

Record last verified: 2017-09

Locations

US (1)