NCT01002105

Brief Summary

This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2009

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

January 27, 2017

Completed
Last Updated

January 27, 2017

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

October 19, 2009

Results QC Date

February 23, 2015

Last Update Submit

November 30, 2016

Conditions

Alcohol Dependence

Keywords

BaclofenAlcoholBaclofen as add-on to standard treatment of alcohol

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Secondary Outcomes (5)

  • Obsessive-Compulsive Drinking Scale Scores

    baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

  • General Health Questionnaire

    baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

  • General Self-Efficacy Scale

    baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

  • Multidimensional Scale of Perceived Social Support

    Baseline, 52 weeks

  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

    baseline, 6 weeks, 12 weeks, 26 weeks, 52 weeks

Study Arms (2)

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.

Drug: Baclofen

Psychosocial intervention

OTHER

Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group

Other: Control group

Interventions

BaclofenDRUG

Baclofen 50mg per day for 12 weeks and psychosocial intervention

Baclofen
Control groupOTHER

psychosocial intervention and placebo for 12 weeks

Also known as: Placebo group
Psychosocial intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Serious hepatic, kidney, lung, neurological and cardiovascular, diseases);
  • Suicide risk, acute psychosis, severe depression, organic brain syndromes;
  • Dependence on psychoactive substances other than nicotine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexander Grinshpoon

Hadera, Mobil Post Hefer 37806, Israel

Location

MeSH Terms

Conditions

Alcoholism

Interventions

BaclofenControl Groups

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Prof. Alexander Grinshpoon
Organization
Shaar Menashe Mental Health Center
alexander.grinshpoon@sm.health.gov.il
+972-4-6278719

Study Officials

  • Alexander M Ponizovsky, MD, PhD

    Ministry of health, State of Israel

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Alexander Grinshpoon

Study Record Dates

First Submitted

October 19, 2009

First Posted

October 27, 2009

Study Start

January 1, 2010

Primary Completion

May 1, 2012

Study Completion

December 1, 2012

Last Updated

January 27, 2017

Results First Posted

January 27, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)