A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lorenzo Leggio, Brown University
ClinicalTrials.gov Identifier:
NCT01076283
First received: February 25, 2010
Last updated: October 15, 2013
Last verified: October 2013
Results First Received: May 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Alcoholism
Interventions: Drug: Baclofen
Drug: Cyproheptadine

  Participant Flow
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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
  Description
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  
NOT COMPLETED     1     0  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  7     7     14  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     7     14  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     2     4  
Male     5     5     10  
Region of Enrollment  
[units: participants]
     
United States     7     7     14  



  Outcome Measures
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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
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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
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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
e-mail: lorenzoleggio@gmail.com


Publications of Results:
Other Publications:


Responsible Party: Lorenzo Leggio, Brown University
ClinicalTrials.gov Identifier: NCT01076283     History of Changes
Other Study ID Numbers: 0906000002
Study First Received: February 25, 2010
Results First Received: May 5, 2013
Last Updated: October 15, 2013
Health Authority: United States: Institutional Review Board