Trial Outcomes & Findings for Baclofen for Treating Anxiety and Alcoholism (NCT NCT01751386)
NCT ID: NCT01751386
Last Updated: 2017-09-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
2 hours
Results posted on
2017-09-18
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
|
Overall Study
COMPLETED
|
18
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Baclofen for Treating Anxiety and Alcoholism
Baseline characteristics by cohort
| Measure |
Baclofen
n=20 Participants
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
n=19 Participants
Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: The analysis included all subjects who took the medication (either baclofen or placebo) and finished the alcohol laboratory session
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.
Outcome measures
| Measure |
Baclofen
n=18 Participants
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
n=16 Participants
Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
|
|---|---|---|
|
Total Amount of Alcohol Consumed During the Alcohol Self Administration (ASA) Session
|
4.11 mini-drinks
Standard Error 0.66
|
4.5 mini-drinks
Standard Error 0.72
|
Adverse Events
Baclofen
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baclofen
n=20 participants at risk
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
n=19 participants at risk
Placebo capsules, similar to baclofen in appearance, texture, taste, and odor
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/20 • 15 days
|
10.5%
2/19 • 15 days
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • 15 days
|
5.3%
1/19 • 15 days
|
|
General disorders
Decreased appetite
|
0.00%
0/20 • 15 days
|
10.5%
2/19 • 15 days
|
|
General disorders
Fatigue
|
0.00%
0/20 • 15 days
|
10.5%
2/19 • 15 days
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.0%
1/20 • 15 days
|
0.00%
0/19 • 15 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • 15 days
|
5.3%
1/19 • 15 days
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/20 • 15 days
|
5.3%
1/19 • 15 days
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • 15 days
|
5.3%
1/19 • 15 days
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • 15 days
|
15.8%
3/19 • 15 days
|
|
Nervous system disorders
Insomnia
|
15.0%
3/20 • 15 days
|
10.5%
2/19 • 15 days
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/20 • 15 days
|
5.3%
1/19 • 15 days
|
|
Nervous system disorders
Somnolence
|
20.0%
4/20 • 15 days
|
26.3%
5/19 • 15 days
|
|
Psychiatric disorders
Depression
|
5.0%
1/20 • 15 days
|
0.00%
0/19 • 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • 15 days
|
5.3%
1/19 • 15 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/20 • 15 days
|
10.5%
2/19 • 15 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • 15 days
|
5.3%
1/19 • 15 days
|
Additional Information
Lorenzo Leggio
National Institute on Alcohol Abuse and Alcoholism
Phone: +1 301 435 9398
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place