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Buprenorphine Naltrexone-P1 A-Cocaine

Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Completed
CT.gov ID
NCT00733720
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
5
Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if the opioid agonist effects of doses of 4/1 mg, 8/2 mg, and 16/4 mg of buprenorphine/naloxone can be completely blocked by 50 mg of oral naltrexone. This study will provide data to support the design of a similar study of the depot formulation of naltrexone and ultimately to study this combination for the treatment of cocaine dependence.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Jan 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Each subject will receive all 3 doses of suboxone and placebo

Drug: Suboxone
4/1mg, 8/2mg 16/4mg
Other Names:
  • buprenorphine/naloxone
  • Subjects will be maintained on 50mg naltrexone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Opioid Effects of study drug [daily]

    Secondary Outcome Measures

    1. Adverse Events [Daily]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Provide written informed consent

    • Be male/female between the ages of 18-55

    • Be in good physical and mental health as determined by interview and physical exam

    • Have a body mass index between 18 and 30, inclusive

    • Have no oral cavity pathology that would interfere with sublingual absorption of buprenorphine/naloxone or placebo

    • Have negative qualitative urine toxicology screen for opioids, cocaine, benzodiazepines, and barbiturates prior to administration of the first dose of naltrexone

    • Be able to comply with protocol requirements

    • If female, have a negative pregnancy test and agree to use an acceptable method of birth control from date of consent and until two weeks after the last administration of study drug or placebo

    Exclusion Criteria:
    • please contact site for more information

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Drug Dependence Research Center San Fransisco California United States 94143

    Sponsors and Collaborators

    • National Institute on Drug Abuse (NIDA)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00733720
    Other Study ID Numbers:
    • N01DA-6-8867
    First Posted:
    Aug 13, 2008
    Last Update Posted:
    Jan 12, 2017
    Last Verified:
    Oct 1, 2009
    Additional relevant MeSH terms:
    Cocaine-Related Disorders
    Naltrexone
    Buprenorphine
    Buprenorphine, Naloxone Drug Combination
    Naloxone

    Study Results

    No Results Posted as of Jan 12, 2017