Aripiprazole for Prevention of Relapse to Cocaine Use - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00780702

Purpose

This study will evaluate whether, compared to placebo, aripiprazole increases the time to relapse to cocaine use in abstinent polydrug users in methadone maintenance therapy. Based on a the results of studies with aripiprazole in a preclinical model of relapse, we hypothesize that aripiprazole will reduce relapse to cocaine use.

Condition	Intervention	Phase
Cocaine Dependence	Drug: aripiprazole Drug: placebo	Phase I

Drug Information available for: Methadone Methadone hydrochloride Aripiprazole 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Aripiprazole for Prevention of Relapse to Cocaine Use in Methadone-Maintenance Patients

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

time to relapse [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

cocaine use [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]
HIV risk behaviors [ Time Frame: 19 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	275
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: aripiprazole Participants receive aripiprazole (orally, up to 15 mg/day) plus standard methadone maintenance (daily oral methadone and weekly individual counseling).
2: Placebo Comparator	Drug: placebo Participants receive identical capsules containing no active medication plus standard methadone maintenance (daily oral methadone and weekly individual counseling).

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

physical dependence on opioids
seeking treatment for opiate and cocaine use
current cocaine use or dependence

Exclusion Criteria:

any medical or psychiatric condition that would compromise participation or contraindicated by study interventions
allergy or hypersensitivity to aripiprazole or methadone
pregnancy or breast-feeding
taking contraindicated medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00780702

Contacts

Contact: Kenzie Preston, PhD	443-740-2326	kpreston@intra.nida.nih.gov
Contact: Kenzie Preston

Locations

United States, Maryland
National Institute on Drug Abuse Intramural Research Program	Recruiting
Baltimore, Maryland, United States, 21224
Contact: Kenzie L. Preston, PhD 443-740-2326 kpreston@intra.nida.nih.gov
Principal Investigator: Kenzie L Preston, PhD

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	National Institute on Drug Abuse Intramural Research Program ( Kenzie L. Preston, Ph.D., Principal Investigator )
Study ID Numbers:	NIDAIRP426
Study First Received:	October 27, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00780702
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Cocaine-Related Disorders
Methadone
Mental Disorders
Substance-Related Disorders

Disorders of Environmental Origin
Aripiprazole
Cocaine

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009