![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
University of North Carolina |
---|---|
Information provided by: | The University of North Carolina, Chapel Hill |
ClinicalTrials.gov Identifier: | NCT00614328 |
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 III |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Feasibility and Tolerability of a Combination of Naltrexone and Baclofen for Alcohol Dependence: A Pilot Study. |
Estimated Enrollment: | 40 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
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
|
2: Active Comparator
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
|
3: Active Comparator
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
|
4: Placebo Comparator
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
|
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.
Ages Eligible for Study: | 25 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Linda S Kalka-Juhl | 919-966-5770 | lkjuhl@med.unc.edu |
United States, North Carolina | |
University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Principal Investigator: James C Garbutt, M.D. |
Principal Investigator: | James C Garbutt, M.D. | UNC-Chapel Hill |
Responsible Party: | UNC-Chapel Hill, Department of Psychiatry ( James C. Garbutt, M.D., Principal Investigator ) |
Study ID Numbers: | 05-2988 GCRC 2497, IRB#05-2988 |
Study First Received: | January 31, 2008 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00614328 |
Health Authority: | United States: Institutional Review Board |
Alcohol Alcohol Abuse Alcohol Drinking |
Mental Disorders Baclofen Naltrexone Alcoholism Substance-Related Disorders |
Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking Ethanol |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Narcotic Antagonists Neuromuscular Agents Pharmacologic Actions Sensory System Agents |
Muscle Relaxants, Central Therapeutic Uses GABA Agonists GABA Agents Peripheral Nervous System Agents Central Nervous System Agents |