Back to resultsPilot Study of Varenicline to Treat Opioid Dependence
Primary Purpose
Chronic Pain, Opioid Dependence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Varenicline
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Varenicline, Chantix, Chronic Pain, Opioid dependence
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Varenicline
Placebo
Arm Description
We will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01436474
Brief Title
Pilot Study of Varenicline to Treat Opioid Dependence
Official Title
The Role of Varenicline in Treating Opioid Dependence: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Dependence
Keywords
Varenicline, Chantix, Chronic Pain, Opioid dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Varenicline
Arm Type
Experimental
Arm Description
We will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
chantix
Intervention Description
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.
Primary Outcome Measure Information:
Title
assessment of opioid withdrawal symptoms
Description
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
Time Frame
45 days
Title
Assessment of cravings at one month following opioid tapering
Description
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
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Hooten, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Varenicline to Treat Opioid Dependence
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