Buprenorphine Naltrexone-P1 A-Cocaine

Cocaine-related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733720
• Other study ID #: N01DA-6-8867
• Status: Completed
• Phase: Phase 1
• First received: August 11, 2008
• Last updated: January 11, 2017
• Start date: August 2008
• Est. completion date: January 2009

Study information

• Verified date: October 2009
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cocaine-related Disorders

Intervention

Drug:
• Suboxone
4/1mg, 8/2mg 16/4mg

Locations

Country	Name	City	State
United States	Drug Dependence Research Center	San Fransisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Effects of study drug		daily	Yes
Secondary	Adverse Events		Daily	Yes