Pilot Study of Varenicline to Treat Opioid Dependence

Phase 1

Completed

• Conditions: Chronic Pain; Opioid Dependence
• Interventions: Drug: Placebo; Drug: Varenicline

• Registration Number: NCT01436474
• Lead Sponsor: Mayo Clinic

Brief Summary

The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	We will be using a placebo in a randomized, controlled, single-blinded trial to look at varenicline for the indication of facilitating opioid tapering in opioid-dependent patients with chronic pain.
Varenicline	Varenicline	We will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study

Primary Outcome Measures

Name	Time	Method
assessment of opioid withdrawal symptoms	45 days	During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning
Assessment of cravings at one month following opioid tapering	45 days	During their treatment, patients are closely monitored by a multidisciplinary team, and there are regular assessments of pain, depression, substance use, and pain-related physical and emotional functioning

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States