IBIS- International Baclofen Interventional Study - IBIS

Phase 1

• Conditions: Preclinical pharmacological and behavioral data indicate that baclofen, a GABAB receptor agonist, modifies some neurobiological factors contributing to alcohol consumption (Cousins et al., 2001). Preliminary baclofen studies (Addolorato et al., 2000; 2002; Flannery et al., 2004) indicate that baclofen may have therapeutic value in alcohol dependence.

• Registration Number: EUCTR2006-003711-51-AT
• Lead Sponsor: Otto M. Lesch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-23
• Last Update Posted: 14 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Inlusion criteria:
1. Men and women between the ages of 18 and 60 meeting DSM-IV criteria for current alcohol dpendence.
2. Must have had at least 2 heavy drinking days (men > 5 drinks/day; 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.
3. Able to understand and sign written informed consent.
4. Must be willing to refrain from drinking for three days prior to randomization day.
5. Express a desire 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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. 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.
3. History of complicated alcohol withdrawal, i.e. withdrawal seizure or delirium tremens.
4. 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.
5. Concurrent use of anticonvulsants, insulin, or oral hypoglycemics.
6. AST, or ALT > 3 times Upper Limit of Normal (ULN), or bilirubin > ULN, or creatinine > ULN.
7. 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.
8. 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).
9. Women who are breastfeeding.
10. Individuals requiring inpatient treatment or more intense outpatient treatment for their alcohol dependence.
11. Participation in any clinical trial within the last 60 days.
12. Court-mandated participation in alcohol treatment or pending incarceration.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Hypothesis 1:<br>Baclofen-treated individuals will significantly reduce their heavy drinking compared to those on placebo.;Secondary Objective: Hypothesis 2:<br>The incidence o side effects and early termination due to side effects will not be significantly different between baclofen and placebo groups.<br>Hypothesis 3:<br>Reductions in craving and anxiety will be significantly greater in baclofen-treated individuals compared to those on placebo.;Primary end point(s): Individuals who experience a worsening of their alcohol problems (chronic intoxications or/and severe withdrawal leading to admission or to a psychopathology that the patient could not follow the protocol or stops to take the medication) and need hospitalization or more intense outpatient treatment will be withdrawn from the study and referred for treatment. Individuals who are experiencing difficult side-effects and who wish to stop the medication will still be encouraged to complete the study and receive BRENDA sessions.