Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.
Information source: University of North Carolina, Chapel Hill
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcohol Dependence
Intervention: Naltrexone, Baclofen, Placebo and Behavior Therapy (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: University of North Carolina, Chapel Hill Official(s) and/or principal investigator(s): James C Garbutt, M.D., Principal Investigator, Affiliation: UNC-Chapel Hill
Summary
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.
Clinical Details
Official title: Feasibility and Tolerability of a Combination of Naltrexone and Baclofen for Alcohol Dependence: A Pilot Study.
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
Primary outcome: 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.
Secondary outcome: 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.
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.
Eligibility
Minimum age: 25 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: July 2007
Last updated: May 5, 2011
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