Effects of Aripiprazole on Cocaine Craving and Self-Administration

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00373880
First received: September 7, 2006
Last updated: August 26, 2008
Last verified: August 2008
  Purpose

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: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
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:

Estimated Enrollment: 20
Study Start Date: April 2005
Estimated Study Completion Date: August 2008
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.

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373880

Locations
United States, New York
Irving Center for Clinical Research
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00373880     History of Changes
Other Study ID Numbers: 4741
Study First Received: September 7, 2006
Last Updated: August 26, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Aripiprazole
Cocaine abuse

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Aripiprazole
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 27, 2014