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Last Updated: Apr 3, 2009 - 1:14:53 AM

                                                                                                                              

Prevention of Relapse to Cocaine Use: Recruiting Participants


By Clinical Trials


Oct 30, 2008 - 3:44:44 AM


 

 

 

Aripiprazole for Prevention of Relapse to Cocaine Use

This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), October 2008

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):

undefined undefined undefined undefined
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
  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
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
 



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