Pilot Study of Varenicline to Treat Opioid Dependence

Chronic Pain Clinical Trial

Official title:

The Role of Varenicline in Treating Opioid Dependence: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436474
• Other study ID #: 11-002062
• Status: Completed
• Phase: Phase 1
• First received: June 3, 2011
• Last updated: January 22, 2013
• Start date: June 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion criteria

• Age>=21 years

• Use of opioids at admission to PRC, with daily morphine equivalent dose>=60mg

• Be able and willing to participate fully in all aspects of the study including one month follow-up after completion of PRC

• Ability to provide informed consent

Exclusion criteria

• Currently using varenicline or other pharmacotherapy for nicotine dependence

• Currently pregnant, lactating, or likely to become pregnant during the trial and not willing to use an acceptable form of contraception;

• History of a major cardiovascular event in the past 6 months including unstable angina, acute myocardial infarction, stroke, or coronary angioplasty;

• Known varenicline allergy

• Use of any medication (e.g., methadone, Suboxone) as maintenance therapy for opiate addiction

• Identification of illicit drugs (e.g., marijuana, cocaine) on the baseline urine toxicology screen

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Dependence
• Opioid-Related Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assessment of opioid withdrawal symptoms	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	45 days	Yes
Primary	Assessment of cravings at one month following opioid tapering	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	45 days	Yes