Buprenorphine Naltrexone-P1 A-Cocaine

This study has been completed.
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
First received: August 11, 2008
Last updated: October 8, 2009
Last verified: October 2009
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 Intervention Phase
Cocaine-Related Disorders
Drug: Suboxone
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Opioid Effects of study drug [ Time Frame: daily ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Daily ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 8
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00733720

United States, California
Drug Dependence Research Center
San Fransisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
  More Information

Responsible Party: Liza Gorgon, NIDA
ClinicalTrials.gov Identifier: NCT00733720     History of Changes
Other Study ID Numbers: N01DA-6-8867 
Study First Received: August 11, 2008
Last Updated: October 8, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 27, 2016