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Baclofen for Treating Anxiety and Alcoholism

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ClinicalTrials.gov Identifier: NCT01751386
Recruitment Status : Completed
First Posted : December 18, 2012
Results First Posted : August 16, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Other
Conditions: Alcoholism
Alcohol Dependence
Alcohol Drinking Related Problems
Alcohol Drinking
Anxiety Disorder
Interventions: Drug: Baclofen
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Baclofen Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
Placebo Placebo capsules, similar to baclofen in appearance, texture, taste, and odor

Participant Flow:   Overall Study
    Baclofen   Placebo
STARTED   20   19 
COMPLETED   18   16 
NOT COMPLETED   2   3 



  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
  Description
Baclofen Baclofen capsules: 15 mg/day (5 mg t.i.d.; titration phase) for 3 days, followed by 30 mg/day (10 mg t.i.d.; target dose) until the alcohol laboratory session; then, 15 mg/day (5 mg t.i.d.; taper down) for three additional days.
Placebo Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
Total Total of all reporting groups

Baseline Measures
   Baclofen   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   19   39 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      20 100.0%      19 100.0%      39 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  20.0%      3  15.8%      7  17.9% 
Male      16  80.0%      16  84.2%      32  82.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      20 100.0%      19 100.0%      39 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1   5.3%      1   2.6% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      13  65.0%      13  68.4%      26  66.7% 
White      6  30.0%      4  21.1%      10  25.6% 
More than one race      1   5.0%      1   5.3%      2   5.1% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session   [ Time Frame: 2 hours ]


  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
No text entered.


  More Information

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


Results Point of Contact:  
Name/Title: Lorenzo Leggio
Organization: National Institute on Alcohol Abuse and Alcoholism
phone: +1 301 435 9398
e-mail: lorenzo.leggio@mail.nih.gov


Publications of Results:
Other Publications:


Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute on Alcohol Abuse and Alcoholism (NIAAA) )
ClinicalTrials.gov Identifier: NCT01751386     History of Changes
Other Study ID Numbers: 130040
13-AA-0040 ( Other Identifier: The National Institutes of Health )
First Submitted: December 13, 2012
First Posted: December 18, 2012
Results First Submitted: July 17, 2017
Results First Posted: August 16, 2017
Last Update Posted: September 18, 2017