Low Dose Naltrexone-buprenorphine Transfer to Vivitrol Injection in Opioid Dependence

PHASE2CompletedINTERVENTIONAL
Enrollment

38

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Opiate Dependence
Interventions
DRUG

very low dose naltrexone

On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.

DRUG

extended release naltrexone

On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.

DRUG

buprenorphine/naloxone

On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.

Trial Locations (1)

27705

Duke University Medical Center / Civitan Building, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alkermes, Inc.

INDUSTRY

lead

Paolo Mannelli

OTHER