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A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking

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ClinicalTrials.gov Identifier: NCT01076283
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : October 17, 2013
Last Update Posted : October 17, 2013
Sponsor:
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
Enrollment 14
Recruitment Details 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 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.
Arm/Group Title Baclofen Cyproheptadine
Hide Arm/Group Description Baclofen 10 mg three times a day (t.i.d.) for 8-10 days Cyproheptadine 2 mg t.i.d. for 8-10 days
Period Title: Overall Study
Started 7 7
Completed 6 7
Not Completed 1 0
Arm/Group Title Baclofen Cyproheptadine Total
Hide Arm/Group Description Baclofen 10 mg three times a day (t.i.d.) for 8-10 days Cyproheptadine 2 mg t.i.d. for 8-10 days Total of all reporting groups
Overall Number of Baseline Participants 7 7 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
7
 100.0%
14
 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 7 participants 7 participants 14 participants
Female
2
  28.6%
2
  28.6%
4
  28.6%
Male
5
  71.4%
5
  71.4%
10
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 14 participants
7 7 14
1.Primary Outcome
Title Alcohol Urge
Hide Description

Whether baclofen, as compared to active placebo, results in diminished cue-reactivity responses to alcohol cues in terms of urge to drink [as measured by the Alcohol Urge Questionnaire (AUQ)] during the Cue Reactivity.

The Alcohol Urge Questionnaire (AUQ) consists of eight statements about the respondent's feelings and thoughts about drinking as they are completing the questionnaire (i.e., right now). The respondent is asked to respond to each statement about alcohol craving via a 7-item Likert scale ranging from "strongly disagree" to "strongly agree." Each item is scored on a 1 to 7 scale (Strongly Disagree = 1 and Strongly Agree = 7). Items 2 and 7 are reverse scored. A total score is computed by summing the item scores and ranges from 8 (lowest craving value) to 56 (highest craving value). Higher scores reflect greater craving (i.e. worse outcome).

Time Frame approximately 8 days after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baclofen Cyproheptadine
Hide Arm/Group Description:
Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
Cyproheptadine 2 mg t.i.d. for 8-10 days
Overall Number of Participants Analyzed 6 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.5  (11.4) 19.4  (19.6)
2.Primary Outcome
Title Alcohol Drinking
Hide Description

Whether baclofen, as compared to active placebo, results in lower quantity of alcohol consumed during the Alcohol Self-Administration (ASA).

Consistent with O'Malley et al. 2002, the ASA paradigm allows to use a fixed-dose (the priming drink), followed by a 2-hour "free-choice" phase when subjects may choose to drink or not up to 8 mini-drinks. Participants receive a monetary compensation of $3 dollars per each mini-drink not consumed; therefore the amount of minidrinks consumed during the 2-hour sessions ranges 0-8, and the monetary compensation ranges $0-24. The quantity of alcohol consumed during the free-choice session is expressed as "standard drinking unit", where a standard drink unit contains about 14 grams of pure alcohol (about 0.6 fluid ounces or 1.2 tablespoons).

Time Frame approximately 8 days after drug administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baclofen Cyproheptadine
Hide Arm/Group Description:
Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
Cyproheptadine 2 mg t.i.d. for 8-10 days
Overall Number of Participants Analyzed 6 7
Mean (Standard Deviation)
Unit of Measure: standard drinking units
0.17  (0.41) 1.43  (2.30)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baclofen Cyproheptadine
Hide Arm/Group Description Baclofen 10 mg three times a day (t.i.d.) for 8-10 days Cyproheptadine 2 mg t.i.d. for 8-10 days
All-Cause Mortality
Baclofen Cyproheptadine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Baclofen Cyproheptadine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/7 (0.00%)      0/7 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Baclofen Cyproheptadine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/7 (85.71%)      3/7 (42.86%)    
Gastrointestinal disorders     
constipation  0/7 (0.00%)  1/7 (14.29%) 
diarrhea  1/7 (14.29%)  0/7 (0.00%) 
nausea  1/7 (14.29%)  0/7 (0.00%) 
flatulence  1/7 (14.29%)  0/7 (0.00%) 
stomachache  1/7 (14.29%)  0/7 (0.00%) 
General disorders     
dental pain  0/7 (0.00%)  1/7 (14.29%) 
Musculoskeletal and connective tissue disorders     
cramps  1/7 (14.29%)  2 0/7 (0.00%) 
neck pain  1/7 (14.29%)  0/7 (0.00%) 
Nervous system disorders     
sleepness  2/7 (28.57%)  1/7 (14.29%) 
sedation  3/7 (42.86%)  2/7 (28.57%) 
insomnia  1/7 (14.29%)  0/7 (0.00%) 
irritability  1/7 (14.29%)  0/7 (0.00%) 
foggy  1/7 (14.29%)  0/7 (0.00%) 
'high'  1/7 (14.29%)  0/7 (0.00%) 
Renal and urinary disorders     
increased urination  1/7 (14.29%)  0/7 (0.00%) 
yellow urine  0/7 (0.00%)  1/7 (14.29%) 
Reproductive system and breast disorders     
loss of libido  1/7 (14.29%)  0/7 (0.00%) 
Very small sample. This pilot trial was primarily aimed to determine a power analysis for future larger trials.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lorenzo Leggio, MD
Organization: Brown University
Phone: 401-863-1000
EMail: lorenzoleggio@gmail.com
Other Publications:
Layout table for additonal information
Responsible Party: Lorenzo Leggio, Brown University
ClinicalTrials.gov Identifier: NCT01076283    
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