Alcohol DependencePhase 1NCT00614328
Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.
A Phase 1 study of Alcohol Dependence, run by University of North Carolina, Chapel Hill.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Alcohol Dependence
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Forty men and women between the ages of 25 to 60 years meeting DSM-IV criteria for current alcohol dependence.
- 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.
- 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.
- Able to understand and sign written informed consent.
- Willingness to engage in treatment and motivation to achieve abstinence or to greatly reduce alcohol consumption.
- Must have a stable residence and be able to identify an individual who could locate subject if needed.
- 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.)
Who cannot join
- 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).
- Patients taking glucocorticoids or immunosuppressants.
- 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.
- Any prior history of, or currently presenting with, withdrawal seizure or delirium tremens.
- AST, or ALT > 3 times Upper Limit of Normal (ULN), or bilirubin > ULN, or estimated glomerular filtration rate < 60.
- 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.
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- 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.
- Concurrent use of anticonvulsants, insulin, or oral hypoglycemics.
- Concurrent use of opiates or any use of opiates within 7 days prior to Naltrexone use.
- Participation in any clinical trial within the last 60 days.
- Court-mandated participation in alcohol treatment or pending incarceration.
- 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).
- If female, pregnant or breastfeeding women and women of child bearing potential who do not practice a medically acceptable form of birth control.
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol Dependence
- Being tested
- Naltrexone, Baclofen, Placebo and Behavior Therapy
- Keywords
- Alcohol, Alcohol Abuse, Alcohol Drinking
- Medical subject headings
- Alcoholism, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone, Baclofen, Placebo and Behavior TherapyDrug
Also called Naltrexone/ ReVia
Naltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Naltrexone (50 mg once a day) + placebo baclofen + behavioral therapy (n=10) Receives: Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy |
| 2 | Active comparator | Placebo naltrexone + baclofen (10 mg t.i.d) + behavior therapy (n=10) Receives: Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy |
| 3 | Active comparator | Baclofen (10 mg t.i.d) + naltrexone (50 mg once per day) + behavior therapy (n=10) Receives: Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy |
| 4 | Placebo comparator | Placebo baclofen + placebo naltrexone + behavior therapy Receives: Drug: Naltrexone, Baclofen, Placebo and Behavior Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Weeks
Secondary outcomes (1)
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- James C Garbutt, M.D., Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614328
- Sponsor's protocol ID
- 05-2988 GCRC 2497
- Other IDs
- IRB#05-2988
- Status last verified
- May 2011
- First submitted
- 31 Jan 2008
- Last updated
- 6 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Tolerability of a Combination of Naltrexone and Baclofen for Alcohol Dependence: A Pilot Study.
- ClinicalTrials.gov ID
- NCT00614328
- Acronym / sponsor ID
- 05-2988 GCRC 2497
- Conditions
- Alcohol Dependence
- Keywords
- Alcohol, Alcohol Abuse, Alcohol Drinking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Naltrexone, Baclofen, Placebo and Behavior TherapyNaltrexone (50 mg once a day) + placebo baclofen + behavioral therapy (n=10) |
| 2 | Active comparator | Drug: Naltrexone, Baclofen, Placebo and Behavior TherapyPlacebo naltrexone + baclofen (10 mg t.i.d) + behavior therapy (n=10) |
| 3 | Active comparator | Drug: Naltrexone, Baclofen, Placebo and Behavior TherapyBaclofen (10 mg t.i.d) + naltrexone (50 mg once per day) + behavior therapy (n=10) |
| 4 | Placebo comparator | Drug: Naltrexone, Baclofen, Placebo and Behavior TherapyPlacebo baclofen + placebo naltrexone + behavior therapy |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Forty men and women between the ages of 25 to 60 years meeting DSM-IV criteria for current alcohol dependence.
- 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.
- 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.
- Able to understand and sign written informed consent.
- Willingness to engage in treatment and motivation to achieve abstinence or to greatly reduce alcohol consumption.
Key exclusion criteria (13 listed)
- 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).
- Patients taking glucocorticoids or immunosuppressants.
- 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.
- Any prior history of, or currently presenting with, withdrawal seizure or delirium tremens.
- AST, or ALT > 3 times Upper Limit of Normal (ULN), or bilirubin > ULN, or estimated glomerular filtration rate < 60.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone, Baclofen, Placebo and Behavior TherapyAlso: Naltrexone/ ReViaNaltrexone 50mg/day for 12 weeks Baclofen 10mg tid = 30mg/day for 12 weeks Behavior Therapy 9 sessions | Drug | 1, 2, 3, 4 |
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.
Time frame: 12 Weeks
1 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.
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James C Garbutt, M.D. principal investigator
UNC-Chapel Hill
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Alcohol Dependence, run by University of North Carolina, Chapel Hill.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2011.