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| Sponsor: | University of North Carolina, Chapel Hill |
|---|---|
| Information provided by: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00614328 |
Purpose
The purpose of this research study is to learn about the use of a combination of two medications, baclofen and naltrexone, for the treatment of alcohol dependence in men and women ages 25-60 years old. Naltrexone is an FDA approved medication for treatment of alcohol dependence. The most widely accepted idea for naltrexone's effect is that it reduces the alcohol "high", which decreases a desire to consume alcohol. As a result, alcoholic patients treated with naltrexone are less likely to relapse to heavy drinking. Furthermore, naltrexone treated patients drink fewer days and are more likely to maintain abstinence.
However, naltrexone does not have any effect on other symptoms that may contribute to relapse such as anxiety, sleep problems and irritability. Baclofen, an FDA approved medication for muscle spasms, may improve some of these symptoms.
Therefore, the purpose of the current study is to gather information on whether adding baclofen to naltrexone is feasible and well tolerated.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcohol Dependence |
Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Feasibility and Tolerability of a Combination of Naltrexone and Baclofen for Alcohol Dependence: A Pilot Study. |
| Enrollment: | 40 |
| Study Start Date: | July 2007 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Naltrexone (50 mg once a day) + placebo baclofen + behavioral therapy (n=10)
|
Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy
Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions
Other Name: Naltrexone/ ReVia
|
|
Active Comparator: 2
Placebo naltrexone + baclofen (10 mg t.i.d) + behavior therapy (n=10)
|
Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy
Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions
Other Name: Naltrexone/ ReVia
|
|
Active Comparator: 3
Baclofen (10 mg t.i.d) + naltrexone (50 mg once per day) + behavior therapy (n=10)
|
Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy
Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions
Other Name: Naltrexone/ ReVia
|
|
Placebo Comparator: 4
Placebo baclofen + placebo naltrexone + behavior therapy
|
Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy
Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions
Other Name: Naltrexone/ ReVia
|
The purpose of this research study is to learn about the use of a combination of two medications, baclofen and naltrexone, for the treatment of alcohol dependence in men and women ages 25-60 years old. Naltrexone is an FDA approved medication for treatment of alcohol dependence. The most widely accepted idea for naltrexone's effect is that it reduces the alcohol "high", which decreases a desire to consume alcohol. As a result, alcoholic patients treated with naltrexone are less likely to relapse to heavy drinking. Furthermore, naltrexone treated patients drink fewer days and are more likely to maintain abstinence.
However, naltrexone does not have any effect on other symptoms that may contribute to relapse such as anxiety, sleep problems and irritability. Baclofen, an FDA approved medication for muscle spasms, may improve some of these symptoms.
Baclofen has been studied for alcoholism in Italy in 45 individuals in two studies. In the two Italian studies, baclofen significantly reduced alcohol withdrawal symptoms and craving for alcohol, as well as the use of alcohol. These data have been supported by the results of our own pilot study conducted here at UNC in 12 subjects with alcohol dependence. That study showed that baclofen was generally well tolerated, and some individuals had significant improvements in their drinking. Furthermore, we have recently completed enrolling 80 alcohol dependent patients into a placebo-controlled study of baclofen and are currently analyzing the data.
Therefore, the purpose of the current study is to gather information on whether adding baclofen to naltrexone is feasible and well tolerated.
Eligibility| Ages Eligible for Study: | 25 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | James C. Garbutt, M.D., Principal Investigator, UNC-Chapel Hill, Department of Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00614328 History of Changes |
| Other Study ID Numbers: | 05-2988 GCRC 2497, IRB#05-2988 |
| Study First Received: | January 31, 2008 |
| Last Updated: | May 5, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Alcohol Alcohol Abuse Alcohol Drinking |
|
Alcoholism Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Baclofen Naltrexone GABA-B Receptor Agonists GABA Agonists GABA Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Muscle Relaxants, Central Neuromuscular Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Narcotic Antagonists Sensory System Agents |