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Buprenorphine Naltrexone-P1 A-Cocaine

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ClinicalTrials.gov Identifier: NCT00733720
Recruitment Status : Completed
First Posted : August 13, 2008
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Study Description
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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
Cocaine-related Disorders Drug: Suboxone Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Opioid Effects of study drug [ Time Frame: daily ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Daily ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733720


Locations
United States, California
Drug Dependence Research Center
San Fransisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Liza Gorgon, NIDA
ClinicalTrials.gov Identifier: NCT00733720     History of Changes
Other Study ID Numbers: N01DA-6-8867
First Posted: August 13, 2008    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: October 2009

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naltrexone
Naloxone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists