Trial Outcomes & Findings for A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking (NCT NCT01076283)
NCT ID: NCT01076283
Last Updated: 2013-10-17
Results Overview
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).
COMPLETED
PHASE2
14 participants
approximately 8 days after drug administration
2013-10-17
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study on the Biobehavioral Mechanisms of Baclofen and Alcohol Drinking
Baseline characteristics by cohort
| Measure |
Baclofen
n=7 Participants
Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
|
Cyproheptadine
n=7 Participants
Cyproheptadine 2 mg t.i.d. for 8-10 days
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: approximately 8 days after drug administrationWhether 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).
Outcome measures
| Measure |
Baclofen
n=6 Participants
Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
|
Cyproheptadine
n=7 Participants
Cyproheptadine 2 mg t.i.d. for 8-10 days
|
|---|---|---|
|
Alcohol Urge
|
22.5 units on a scale
Standard Deviation 11.4
|
19.4 units on a scale
Standard Deviation 19.6
|
PRIMARY outcome
Timeframe: approximately 8 days after drug administrationWhether 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).
Outcome measures
| Measure |
Baclofen
n=6 Participants
Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
|
Cyproheptadine
n=7 Participants
Cyproheptadine 2 mg t.i.d. for 8-10 days
|
|---|---|---|
|
Alcohol Drinking
|
0.17 standard drinking units
Standard Deviation 0.41
|
1.43 standard drinking units
Standard Deviation 2.30
|
Adverse Events
Baclofen
Cyproheptadine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baclofen
n=7 participants at risk
Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
|
Cyproheptadine
n=7 participants at risk
Cyproheptadine 2 mg t.i.d. for 8-10 days
|
|---|---|---|
|
Nervous system disorders
sleepness
|
28.6%
2/7
|
14.3%
1/7
|
|
Renal and urinary disorders
increased urination
|
14.3%
1/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
cramps
|
14.3%
1/7 • Number of events 2
|
0.00%
0/7
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/7
|
14.3%
1/7
|
|
Renal and urinary disorders
yellow urine
|
0.00%
0/7
|
14.3%
1/7
|
|
Nervous system disorders
sedation
|
42.9%
3/7
|
28.6%
2/7
|
|
Gastrointestinal disorders
diarrhea
|
14.3%
1/7
|
0.00%
0/7
|
|
Reproductive system and breast disorders
loss of libido
|
14.3%
1/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
nausea
|
14.3%
1/7
|
0.00%
0/7
|
|
Nervous system disorders
insomnia
|
14.3%
1/7
|
0.00%
0/7
|
|
Nervous system disorders
irritability
|
14.3%
1/7
|
0.00%
0/7
|
|
Gastrointestinal disorders
flatulence
|
14.3%
1/7
|
0.00%
0/7
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
14.3%
1/7
|
0.00%
0/7
|
|
General disorders
dental pain
|
0.00%
0/7
|
14.3%
1/7
|
|
Gastrointestinal disorders
stomachache
|
14.3%
1/7
|
0.00%
0/7
|
|
Nervous system disorders
foggy
|
14.3%
1/7
|
0.00%
0/7
|
|
Nervous system disorders
'high'
|
14.3%
1/7
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place