Alcohol DependencePhase 2/3NCT00877734
Efficacy and Tolerability of Baclofen for Alcohol Dependence
A Phase 2/3 study testing baclofen and BRENDA counseling in people with Alcohol Dependence, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid) baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- baclofen and BRENDA counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2007
- Phase
- Phase 2/3
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 18 and 60 meeting DSM-IV criteria for current alcohol dependence.
- Must have had at least 2 heavy drinking days (men > 5 drinks/days; women > 4 drinks/day) 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 screening.
- Able to understand and sign written informed consent.
- Must be willing to refrain from drinking for three days prior to randomization day.
- Express a desire 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.
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).
- Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, or severe depression; suicidal ideation; substance use disorder other than alcohol or nicotine dependence or cannabis abuse.
- History of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens.
- Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics. However, subjects who have been on stable doses of the antidepressants fluoxetine, sertraline, paroxetine, citalopram, ecitalapram, trazodone or venlafaxine for two months will be eligible. Subjects who have been taking benzodiazepines for alcohol detoxification will be required to have a washout period of at least five half-lives (approximately 5 days) from those medications before being randomized.
- Concurrent use of anticonvulsants, insulin, or oral hypoglycemics.
- AST, or ALT > 3 times Upper Limit of Normal (ULN), or bilirubin > ULN, or creatinine > ULN.
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- Positive urine toxicology screen with the exception of cannabis. Individuals with positive cannabis screens will be excluded only if they have a history of cannabis dependence.
- Pregnant women and women of childbearing potential who do not practice a medically acceptable form of birth control (oral or depot contraceptive, or barrier methods such as diaphragm or condom with spermicidal).
- Women who are breastfeeding.
- Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence.
- Participation in any clinical trial within the last 60 days.
- Court-mandated participation in alcohol treatment or pending incarceration.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill School of Medicine
Chapel Hill, North Carolina, 27599-7160
About this study
Official title: Phase IIIa Trial of Baclofen for Alcohol Dependence
This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid) baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Subjects will receive BRENDA counseling over the 12 weeks of the trial. The Timeline Followback (TLFB) method will be used to assess drinking patterns. The primary outcome is % heavy drinking during the trial.
Read the detailed description
The study will explore the efficacy and tolerability of a 12-week regimen of 10 mg t.i.d. baclofen vs. placebo in conjunction with behavioral therapy for reducing heavy drinking in 80 alcohol dependent individuals. Prior studies (Addolorato et al. 2000, 2002; Flannery et al., 2004) have found that baclofen reduces self-reported anxiety and craving; therefore, the proposed study also will assess baclofen's ability to reduce symptoms of these affective states. Furthermore, in our pilot study (Flannery et al, 2004), women appeared to respond more consistently than men, and therefore the study will also be balanced by gender.
- Conditions
- Alcohol Dependence
- Being tested
- baclofen, placebo, BRENDA counseling
- Keywords
- alcohol dependence, baclofen, pharmacotherapy, women
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baclofenDrug
Also called Lioresal
10 mg Baclofen administered tid for 11 weeks
placeboDrug
Placebo administered tid for 11 weeks
BRENDA counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Baclofen Receives: Drug: baclofen; Behavioral: BRENDA counseling |
| 2 | Placebo comparator | Placebo Receives: Drug: placebo; Behavioral: BRENDA counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
% heavy drinking days
Measured: 2 years
Secondary outcomes (4)
% relapse
Measured: 2 years
% abstinent days
Measured: 2 years
depression symptoms
Measured: 2 years
anxiety symptoms
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startApr 2005
- Primary completionMay 2007
- Study completionJun 2007
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Investigators
- James C Garbutt, MD, Principal investigator, UNC Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877734
- Sponsor's protocol ID
- baclofen-unc-0507
- Status last verified
- Apr 2011
- First submitted
- 7 Feb 2008
- Last updated
- 14 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIa Trial of Baclofen for Alcohol Dependence
- ClinicalTrials.gov ID
- NCT00877734
- Acronym / sponsor ID
- baclofen-unc-0507
- Conditions
- Alcohol Dependence
- Keywords
- alcohol dependence, baclofen, pharmacotherapy, women
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Apr 2009 (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.
This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid) baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Subjects will receive BRENDA counseling over the 12 weeks of the trial. The Timeline Followback (TLFB) method will be used to assess drinking patterns. The primary outcome is % heavy drinking during the trial.
Detailed description
The study will explore the efficacy and tolerability of a 12-week regimen of 10 mg t.i.d. baclofen vs. placebo in conjunction with behavioral therapy for reducing heavy drinking in 80 alcohol dependent individuals. Prior studies (Addolorato et al. 2000, 2002; Flannery et al., 2004) have found that baclofen reduces self-reported anxiety and craving; therefore, the proposed study also will assess baclofen's ability to reduce symptoms of these affective states. Furthermore, in our pilot study (Flannery et al, 2004), women appeared to respond more consistently than men, and therefore the study will also be balanced by gender.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: baclofen, Behavioral: BRENDA counselingBaclofen |
| 2 | Placebo comparator | Drug: placebo, Behavioral: BRENDA counselingPlacebo |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women between the ages of 18 and 60 meeting DSM-IV criteria for current alcohol dependence.
- Must have had at least 2 heavy drinking days (men > 5 drinks/days; women > 4 drinks/day) 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 screening.
- Able to understand and sign written informed consent.
- Must be willing to refrain from drinking for three days prior to randomization day.
- Express a desire to achieve abstinence or to greatly reduce alcohol consumption.
Key exclusion criteria (12 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).
- Clinically significant psychiatric illness including any psychotic disorder, bipolar disorder, or severe depression; suicidal ideation; substance use disorder other than alcohol or nicotine dependence or cannabis abuse.
- History of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens.
- Concurrent use of any psychotropic medication including antidepressants, mood stabilizers, antipsychotics, anxiolytics, stimulants, or hypnotics. However, subjects who have been on stable doses of the antidepressants fluoxetine, sertraline, paroxetine, citalopram, ecitalapram, trazodone or venlafaxine for two months will be eligible. Subjects who have been taking benzodiazepines for alcohol detoxification will be required to have a washout period of at least five half-lives (approximately 5 days) from those medications before being randomized.
- Concurrent use of anticonvulsants, insulin, or oral hypoglycemics.
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 |
|---|---|---|
| baclofenAlso: Lioresal10 mg Baclofen administered tid for 11 weeks | Drug | 1 |
| placeboPlacebo administered tid for 11 weeks | Drug | 2 |
| BRENDA counseling | Behavioural | 1, 2 |
Primary outcome
% heavy drinking days
Time frame: 2 years
4 secondary outcomes
% relapse
Time frame: 2 years
% abstinent days
Time frame: 2 years
depression symptoms
Time frame: 2 years
anxiety symptoms
Time frame: 2 years
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 14 Sep 2012.
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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, MD principal investigator
UNC Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing baclofen and BRENDA counseling in people with Alcohol Dependence, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 6 inclusion and 12 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 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
% heavy drinking days (time frame: 2 years). 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 14 Sep 2012.