Expired Study
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San Fransisco, California 94143


Purpose:

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.


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


Study is Available At:


Original ID:

N01DA-6-8867


NCT ID:

NCT00733720


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Drug Abuse (NIDA)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Crosso


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

8


Enrollment Type:

Anticipated


Study Dates

Start Date:August 2008
Completion Date:January 2009
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:October 2009
Last Changed Date:January 11, 2017
First Received Date:August 11, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Adverse Events
Time Frame:Daily
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Opioid Effects of study drug
Time Frame:daily
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:Suboxone
Description:4/1mg, 8/2mg 16/4mg
Arm Name:1
Other Name:buprenorphine/naloxone

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Description:Each subject will receive all 3 doses of suboxone and placebo

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Drug Abuse (NIDA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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