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Buprenorphine Naltrexone-P1 A-Cocaine

Primary Purpose

Cocaine-related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Suboxone
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine-related Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Drug Dependence Research Center

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Each subject will receive all 3 doses of suboxone and placebo

Outcomes

Primary Outcome Measures

Opioid Effects of study drug

Secondary Outcome Measures

Adverse Events

Full Information

First Posted
August 11, 2008
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00733720
Brief Title
Buprenorphine Naltrexone-P1 A-Cocaine
Official Title
Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine-related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Each subject will receive all 3 doses of suboxone and placebo
Intervention Type
Drug
Intervention Name(s)
Suboxone
Other Intervention Name(s)
buprenorphine/naloxone, Subjects will be maintained on 50mg naltrexone
Intervention Description
4/1mg, 8/2mg 16/4mg
Primary Outcome Measure Information:
Title
Opioid Effects of study drug
Time Frame
daily
Secondary Outcome Measure Information:
Title
Adverse Events
Time Frame
Daily

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Drug Dependence Research Center
City
San Fransisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Buprenorphine Naltrexone-P1 A-Cocaine

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