Pilot Study of Varenicline to Treat Opioid Dependence

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

September 30, 2012

Study Completion Date

December 31, 2012

Conditions
Chronic PainOpioid Dependence
Interventions
DRUG

Varenicline

Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.

DRUG

Placebo

Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER

NCT01436474 - Pilot Study of Varenicline to Treat Opioid Dependence | Biotech Hunter | Biotech Hunter