NCT00032968

Buprenorphine/Naloxone Versus Clonidine for Outpatient Opiate Detoxification - 1

Buprenorphine/Naloxone Versus Clonidine For Out-patient Opiate Detoxification

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 341 (planned)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess buprenorphine/naloxone versus clonidine for outpatient opiate detoxification.

Detailed description

Patients randomized to the BUP/NX arm will receive daily doses for 13 days with sublingual administration of 2 mg buprenorphine/0.5 mg naloxone tablet(s) and/or an 8 mg buprenorphine/2.0 mg naloxone tablet(s). The starting dose on day 1 is 4 mg/1 mg BUP/NX with an additional 4 mg/1 mg, if needed, escalating in a step-wise manner to 16 mg/4 mg BUP/NX on day 3 and tapering to 2 mg/ 0.5 mg BUP/NX by days 12 to 13. Patients randomized to the clonidine arm will receive oral clonidine (0.05 to 0.1 mg depending upon weight) every 4 to 6 hours for 24 hours not to exceed 0.6 mg total on day 1. On day 2, a clonidine transdermal patch will be applied (0.1 mg/day/7-day patch with number of patches adjusted by weight). Oral clonidine will continue to be given on the second day of detoxification and increased to 0.2 mg every 6 hours or 0.1 mg every 3 hours not to exceed 0.8 mg over 24 hours. Patches will be worn all 13 days of detoxification. The dose of clonidine will be adjusted according to the proposed detoxification schedule, patient's weight, tolerance, and systolic blood pressure. Patients will receive counseling according to procedures in existence at each CTP throughout the study. Self-help detoxification handbooks will be distributed to all study participants.

Conditions

• Heroin Dependence
• Morphine Dependence
• Substance Withdrawal Syndrome

Interventions

Type	Name	Description
DRUG	Buprenorphine/naloxone

Timeline

• Start date: 2001-01-01
• Primary completion: 2002-08-01
• Completion: 2002-08-01
• First posted: 2002-04-08
• Last updated: 2017-01-12

Locations

7 sites across 1 country: United States