Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.

May 5, 2011 updated by: University of North Carolina, Chapel Hill

Feasibility and Tolerability of a Combination of Naltrexone and Baclofen for Alcohol Dependence: A Pilot Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Forty men and women between the ages of 25 to 60 years meeting DSM-IV criteria for current alcohol dependence.
  2. Subjects must either have been admitted to UNC Hospitals for a medical detoxification from alcohol and be receiving benzodiazepines for detoxification or recruited from the general population.
  3. Must have had at least 2 heavy drinking days (≥5 drinks/day for men or ≥4 drinks/day for women) per week, on average and an average overall consumption of 21 drinks/week or more for men and 14 drinks/week or more for women during the 4 weeks prior to admission or screening and no more than three months of abstinence in the previous year.
  4. Able to understand and sign written informed consent.
  5. Willingness to engage in treatment and motivation to achieve abstinence or to greatly reduce alcohol consumption.
  6. Must have a stable residence and be able to identify an individual who could locate subject if needed.
  7. Must have the logistical ability to come to study visits.(This study is being conducted in Chapel Hill, NC. Therefore participants must be able to attend each clinic visit for 12 weeks.)

Exclusion Criteria:

  1. Clinically significant medical disease that might interfere with the evaluation of the study medication or present a safety concern (e.g., cirrhosis, kidney impairment, unstable hypertension, hypotension, diabetes mellitus, seizure disorder).
  2. Patients taking glucocorticoids or immunosuppressants.
  3. Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, severe depression, persistent suicidal ideation or suicide attempt, or substance use dependence other than alcohol or nicotine.
  4. Any prior history of, or currently presenting with, withdrawal seizure or delirium tremens.
  5. AST, or ALT > 3 times Upper Limit of Normal (ULN), or bilirubin > ULN, or estimated glomerular filtration rate < 60.
  6. Positive urine toxicology screen with the exception of cannabis or cocaine for inpatients only. Patients recruited from the general population who present with a positive urine toxicology screen other than cannabis will be excluded. Any subject with positive cannabis or cocaine screens will be excluded if they have a history of dependence.
  7. Concurrent use of mood stabilizers, antipsychotics, stimulants, or hypnotics. Use of benzodiazepines is prohibited except during the withdrawal period for inpatients. Antidepressant medication is permitted.
  8. Concurrent use of anticonvulsants, insulin, or oral hypoglycemics.
  9. Concurrent use of opiates or any use of opiates within 7 days prior to Naltrexone use.
  10. Participation in any clinical trial within the last 60 days.
  11. Court-mandated participation in alcohol treatment or pending incarceration.
  12. For inpatients, lack of urine toxicology or pregnancy test done on date of hospital admission. Outpatient subjects will have a urine toxicology screen and a pregnancy test done (if female).
  13. If female, pregnant or breastfeeding women and women of child bearing potential who do not practice a medically acceptable form of birth control.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • Naltrexone/ ReVia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
This is an exploratory study to gain experience with the combination of baclofen+naltrexone and to gather pilot data on cytokine levels. Initial interest is in recruitment and retention of study participants.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Randomized participants complying with study visits and those lost to follow-up will be calculated.Compliance and follow-up are distinct because some participants may provide drinking patterns during follow-up regardless if they continue treatment.
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Investigators

  • Principal Investigator: James C Garbutt, M.D., UNC-Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 31, 2008

First Submitted That Met QC Criteria

February 12, 2008

First Posted (Estimate)

February 13, 2008

Study Record Updates

Last Update Posted (Estimate)

May 6, 2011

Last Update Submitted That Met QC Criteria

May 5, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-2988 GCRC 2497
  • IRB#05-2988

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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