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Effects of Aripiprazole on Cocaine Craving and Self-Administration

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute Identifier:
First received: September 7, 2006
Last updated: October 25, 2016
Last verified: October 2016
The purpose of this study is to investigate whether aripiprazole will decrease cocaine self-administration, subjective effects and cravings compared to placebo.

Condition Intervention Phase
Cocaine Abuse Drug: Aripiprazole Drug: Cocaine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Aripiprazole on Cocaine Craving and Self-Administration

Resource links provided by NLM:

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • cocaine self-administration [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • cocaine's subjective effects [ Time Frame: 5 days ]

Other Outcome Measures:
  • cocaine's cardiovascular effects [ Time Frame: 5 days ]

Enrollment: 26
Study Start Date: April 2005
Study Completion Date: September 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aripiprazole, cocaine
aripiprazole (15 mg/day) smoked cocaine dose-response curve (0, 12, 25, 50 mg)
Drug: Aripiprazole Drug: Cocaine
Placebo Comparator: placebo, cocaine
smoked cocaine dose-response curve (0, 12, 25, 50 mg)
Drug: Cocaine

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.

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00373880

United States, New York
Irving Center for Clinical Research
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
  More Information

Responsible Party: New York State Psychiatric Institute Identifier: NCT00373880     History of Changes
Other Study ID Numbers: 4741
Study First Received: September 7, 2006
Last Updated: October 25, 2016

Keywords provided by New York State Psychiatric Institute:
Cocaine abuse

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents processed this record on July 21, 2017