Randomized, Double-Blind Cross-Over Trial Of Buprenorphine and Low-Dose Naloxone Versus Buprenorphine

NACompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

September 30, 2008

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Pain
Interventions
DRUG

buprenorphine and low-dose naloxone

each participant will be randomly assigned to order of study drug administration in a double-blind manner. Five doses of first study drug will be administered for 5 days, with each administration following the previous dose by not more than 2 days. Administration of the second study drug, buprenorphine only, will follow at least 2 days after the completion of the first study drug with the same administration criteria. Medication will be administered IV, and assessments will continue for 6 hours after administration. Study drugs include 1) buprenorphine 0.3mg and naloxone 0.02mg and, 2) buprenorphine 0.3mg.

DRUG

buprenorphine alone

each participant will be randomly assigned to order of study drug administration in a double-blind manner. Five doses of first study drug will be administered for 5 days, with each administration following the previous dose by not more than 2 days. Administration of the second study drug will follow at least 2 days after the completion of the first study drug with the same administration criteria. Medication will be administered IV, and assessments will continue for 6 hours after administration. Study drugs include 1) buprenorphine 0.3mg and naloxone 0.02mg and, 2) buprenorphine 0.3mg.

Trial Locations (1)

90025'

UCLA Integrated Substance Abuse Programs Outpatient Research Center, Los Angeles

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Indivior Inc.

INDUSTRY

lead

University of California, Los Angeles

OTHER

NCT00679458 - Randomized, Double-Blind Cross-Over Trial Of Buprenorphine and Low-Dose Naloxone Versus Buprenorphine | Biotech Hunter | Biotech Hunter