Alcohol DependencePhase 4NCT01002105
Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients
A Phase 4 study testing Baclofen in people with Alcohol Dependence, run by Sha'ar Menashe Mental Health Center at 1 site in Israel.
Trial summary
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Baclofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Dec 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
- Seeking treatment with the aim to stop alcohol consumption;
- Age ranging from 18 to 60 years;
- Last alcohol intake reported in the 24 h preceding observation;
- Presence of a referred family member;
- Written informed consent provision.
Who cannot join
- Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
- Suicide risk, acute psychosis, severe depression, organic brain syndromes;
- Dependence on psychoactive substances other than nicotine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients and Its Effect on Quality of Life, Clinical and Psychosocial Features: A 12-Week Double-Blind Randomized Controlled Trial
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.
Read the detailed description
Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving; distress and depression levels; self-efficacy; social support from family, friends and significant others; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.
- Conditions
- Alcohol Dependence
- Being tested
- Baclofen, Control group
- Keywords
- Baclofen, Alcohol, Baclofen as add-on to standard treatment of alcohol
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Baclofen 50mg per day for 12 weeks and psychosocial intervention
Control groupOther
Also called Placebo group
psychosocial intervention and placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Baclofen | Experimental | The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. Receives: Drug: Baclofen |
| Psychosocial intervention | Other | Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Abstinent Days
Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.
Measured: one year
Secondary outcomes (5)
Obsessive-Compulsive Drinking Scale Scores
Used to evaluate self-reported alcohol craving. 14 items that provided a total (OCDS) as well as two subscale scores - obsessive drinking (OD) and compulsive drinking (CD). Each of the 14 items are scored from 0 to 4 with the inclusion of 4 split items with only the higher of the two scored items to be used in the total or subscale scores. The OCDS total score ranges from 0-40; the subscales both range from 0 to 20. On all scales, higher scores represent a worse outcome. Data for CD at 6 weeks not available to report
Measured: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
General Health Questionnaire
The General Health Questionnaire measures whether the respondent has recently experienced a particular symptom or behavior and ranges from 0-much less than usual to 3-much more than usual. Total scores range from 0 to 36 and vary by study population: total scores of about 11-12 are typical, and a score higher than 20 suggests severe problems and psychological distress.
Measured: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
General Self-Efficacy Scale
The GSES measures one's belief in his/her ability to cope with stressful situations. The scale consists of 10 items (e.g. "Usually I am able to control a situation" or "In unexpected situations, I always know how I must behave myself"). Responses are rated on a 4- point Likert-scale ranging from "absolutely not true" (weighted as 1) to "absolutely true" (weighted as 4), where the higher GSES total scores indicate stronger self-efficacy beliefs.All responses are added to a sum score. The range is from 10 to 40 points with a higher score indicating more self-efficiency.
Measured: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Multidimensional Scale of Perceived Social Support
The MSPSS is a self-report instrument for assessment of emotional help and the level of satisfaction with the social support obtained from three sources - family, friends and significant others. The scale includes 12 items, each of which refer to the people to whom the respondent would turn if he/she had problems of a personal, health or family nature, as well as financial and employment problems. Responses are scored on a 7-point scale from 1 ('completely disagree') to 7 ('completely agree'). The MSPSS index and three subscales - family, friends and significant others - are computed. MSPSS total score ranged from 12 to 84, with a higher score indicating greater satisfaction with total support. Subscores ranged from 4 to 28, with higher score indicating greater satisfaction.
Measured: Baseline, 52 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report form composed of 16 items, each rated on a 5-point scale that indicates the degree of enjoyment or satisfaction with: physical health; social relations; ability to function in daily life; ability to get around physically; mood; family relations; sexual drive and interest; ability to work on hobbies, work, leisure time activities; economic status; household activities; and living/housing situation. A total score of 1 to 15 items was computed while item 16 assessing "overall life satisfaction" was not included to avoid exaggerated scores. The total score was averaged from items 1 to 15 and ranged from 1 to 5, with higher scores indicating higher satisfaction.
Measured: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sha'ar Menashe Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Israel
- Responsible party
- Principal investigator, Alexander Grinshpoon, Sha'ar Menashe Mental Health Center
- Investigators
- Alexander M Ponizovsky, MD, PhD, Study director, Ministry of health, State of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002105
- Sponsor's protocol ID
- AGRIN4CTIL
- Status last verified
- Nov 2016
- First submitted
- 19 Oct 2009
- Last updated
- 27 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baclofen as Add-On to Standard Treatment of Alcohol- Dependent Patients and Its Effect on Quality of Life, Clinical and Psychosocial Features: A 12-Week Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01002105
- Acronym / sponsor ID
- AGRIN4CTIL
- Conditions
- Alcohol Dependence
- Keywords
- Baclofen, Alcohol, Baclofen as add-on to standard treatment of alcohol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sha'ar Menashe Mental Health CenterUniversity, hospital or other
- Collaborators
- Ministry of Health, Israel
- Study start
- Jan 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Posted 27 Jan 2017
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 Baclofen as an add-on to standard treatment for alcohol-dependent patients.
Detailed description
Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving; distress and depression levels; self-efficacy; social support from family, friends and significant others; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baclofen | Experimental | Drug: BaclofenThe study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. |
| Psychosocial intervention | Other | Other: Control groupIntervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- ICD-10 diagnosis of alcohol dependence (World Health Organization, 1993);
- Seeking treatment with the aim to stop alcohol consumption;
- Age ranging from 18 to 60 years;
- Last alcohol intake reported in the 24 h preceding observation;
- Presence of a referred family member;
Key exclusion criteria (3 listed)
- Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
- Suicide risk, acute psychosis, severe depression, organic brain syndromes;
- Dependence on psychoactive substances other than nicotine.
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 |
|---|---|---|
| BaclofenBaclofen 50mg per day for 12 weeks and psychosocial intervention | Drug | Baclofen |
| Control groupAlso: Placebo grouppsychosocial intervention and placebo for 12 weeks | Other | Psychosocial intervention |
Primary outcome
Percent Abstinent Days
Time frame: one year
Percent abstinent days at 52 weeks. % of abstinent days were assessed by (1) patient's self-evaluation; (2) family member interview; (3) calculation of cumulative abstinence duration (CAD), defined as the total number of days of abstinence, Abstinent days was calculated for each Arm as a whole.
5 secondary outcomes
Obsessive-Compulsive Drinking Scale Scores
Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
General Health Questionnaire
Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
General Self-Efficacy Scale
Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Multidimensional Scale of Perceived Social Support
Time frame: Baseline, 52 weeks
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Alexander M Ponizovsky, MD, PhD study director
Ministry of health, State of Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baclofen in people with Alcohol Dependence, run by Sha'ar Menashe Mental Health Center at 1 site in Israel.
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 3 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 27 Jan 2017. 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 Israel. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Abstinent Days (time frame: one year). 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 27 Jan 2017.