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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
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Baclofen Placebo
Hide Arm/Group Description 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 capsules, similar to baclofen in appearance, texture, taste, and odor
Period Title: Overall Study
Started 20 19
Completed 18 16
Not Completed 2 3
Arm/Group Title Baclofen Placebo Total
Hide Arm/Group Description 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 capsules, similar to baclofen in appearance, texture, taste, and odor Total of all reporting groups
Overall Number of Baseline Participants 20 19 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 participants
Female
4
  20.0%
3
  15.8%
7
  17.9%
Male
16
  80.0%
16
  84.2%
32
  82.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 19 participants 39 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%
1.Primary Outcome
Title Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session
Hide Description Amount of alcohol was measured as the number of mini-drinks each participant decided to drink (0-8 mini-drinks). The alcohol content of each mini-drink was calculated based on the participants' total body water, and was designed to raise the blood alcohol concentration by 0.015 g/dL.
Time Frame 2 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis included all subjects who took the medication (either baclofen or placebo) and finished the alcohol laboratory session
Arm/Group Title Baclofen Placebo
Hide Arm/Group Description:
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 capsules, similar to baclofen in appearance, texture, taste, and odor
Overall Number of Participants Analyzed 18 16
Mean (Standard Error)
Unit of Measure: mini-drinks
4.11  (0.66) 4.5  (0.72)
Time Frame 15 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baclofen Placebo
Hide Arm/Group Description 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 capsules, similar to baclofen in appearance, texture, taste, and odor
All-Cause Mortality
Baclofen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Baclofen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Baclofen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/20 (45.00%)   7/19 (36.84%) 
Gastrointestinal disorders     
Abdominal distension   0/20 (0.00%)  2/19 (10.53%) 
Constipation   1/20 (5.00%)  1/19 (5.26%) 
General disorders     
Decreased appetite   0/20 (0.00%)  2/19 (10.53%) 
Fatigue   0/20 (0.00%)  2/19 (10.53%) 
Metabolism and nutrition disorders     
Increased appetite   1/20 (5.00%)  0/19 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain   1/20 (5.00%)  1/19 (5.26%) 
Muscular weakness   0/20 (0.00%)  1/19 (5.26%) 
Nervous system disorders     
Dizziness   1/20 (5.00%)  1/19 (5.26%) 
Headache   2/20 (10.00%)  3/19 (15.79%) 
Insomnia   3/20 (15.00%)  2/19 (10.53%) 
Memory impairment   0/20 (0.00%)  1/19 (5.26%) 
Somnolence   4/20 (20.00%)  5/19 (26.32%) 
Psychiatric disorders     
Depression   1/20 (5.00%)  0/19 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough   0/20 (0.00%)  1/19 (5.26%) 
Nasal congestion   0/20 (0.00%)  2/19 (10.53%) 
Skin and subcutaneous tissue disorders     
Rash   1/20 (5.00%)  1/19 (5.26%) 
Indicates events were collected by systematic assessment
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
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