A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01076283
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Information provided by (Responsible Party):
Lorenzo Leggio, Brown University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Drug: Baclofen
Drug: Cyproheptadine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Potential participants came for an in-person screening (Visit 1) at the Brown University Center for Alcohol and Addiction Studies (CAAS). At Visit 2 (day 1), participants were randomized to either baclofen or active placebo by using a 3-urn variable procedure (Stout et al., 1994), i.e. gender, FH of alcoholism and baseline drinks per drinking day.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
19 participants signed the consent document; 5 of them did not satisfy the protocol-specific inclusion/exclusion criteria, therefore they were excluded from the trial. The remaining 14 subjects were assigned to the study groups.

Reporting Groups
Baclofen Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
Cyproheptadine Cyproheptadine 2 mg t.i.d. for 8-10 days

Participant Flow:   Overall Study
    Baclofen   Cyproheptadine
STARTED   7   7 
COMPLETED   6   7 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Baclofen Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
Cyproheptadine Cyproheptadine 2 mg t.i.d. for 8-10 days
Total Total of all reporting groups

Baseline Measures
   Baclofen   Cyproheptadine   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   7   7   14 
>=65 years   0   0   0 
[Units: Participants]
Female   2   2   4 
Male   5   5   10 
Region of Enrollment 
[Units: Participants]
United States   7   7   14 

  Outcome Measures

1.  Primary:   Alcohol Urge   [ Time Frame: approximately 8 days after drug administration ]

2.  Primary:   Alcohol Drinking   [ Time Frame: approximately 8 days after drug administration ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Very small sample. This pilot trial was primarily aimed to determine a power analysis for future larger trials.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Lorenzo Leggio, MD
Organization: Brown University
phone: 401-863-1000

Publications of Results:
Other Publications:

Responsible Party: Lorenzo Leggio, Brown University Identifier: NCT01076283     History of Changes
Other Study ID Numbers: 0906000002
First Submitted: February 25, 2010
First Posted: February 26, 2010
Results First Submitted: May 5, 2013
Results First Posted: October 17, 2013
Last Update Posted: October 17, 2013