Pilot Study of Varenicline to Treat Opioid Dependence
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by (Responsible Party):
W. Michael Hooten, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01436474
First received: June 3, 2011
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
The objective of this proposal is to explore the potential of varenicline as a pharmacotherapeutic agent for opioid dependence and addiction.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Pain Opioid Dependence |
Drug: Varenicline Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Role of Varenicline in Treating Opioid Dependence: A Pilot Study |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- assessment of opioid withdrawal symptoms [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]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 [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]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
| Enrollment: | 21 |
| Study Start Date: | June 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Varenicline
We will be comparing Varenicline to placebo in a single-blinded placebo controlled, randomized study
|
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.
Other Name: Chantix
|
|
Placebo Comparator: 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.
|
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.
Other Name: chantix
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | W. Michael Hooten, M.D., Mayo Clinic |
| ClinicalTrials.gov Identifier: | NCT01436474 History of Changes |
| Other Study ID Numbers: | 11-002062 |
| Study First Received: | June 3, 2011 |
| Last Updated: | January 22, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Keywords provided by Mayo Clinic:
|
Varenicline Chantix Chronic Pain Opioid dependence |
Additional relevant MeSH terms:
|
Opioid-Related Disorders Substance-Related Disorders Mental Disorders Analgesics, Opioid Varenicline Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013