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Completed

NCT Number: NCT00733720

Buprenorphine Naltrexone-P1 A-Cocaine

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.

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Key information

Conditions

Cocaine-Related Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Drug Dependence Research Center

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Suboxone

Drug

4/1mg, 8/2mg 16/4mg

Other names: buprenorphine/naloxone, Subjects will be maintained on 50mg naltrexone

Primary outcomes

  1. Opioid Effects of study drug

    Time frame: daily

Secondary outcomes

  1. Adverse Events

    Time frame: Daily

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Attenuation of Opioid Effects of Three Different Doses of Sublingual Buprenorphine / Naloxone by Oral Naltrexone in Healthy Volunteers

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 13, 2008
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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