Trial Outcomes & Findings for Efficacy and Safety of High Dose Baclofen for Alcohol Dependence (NCT NCT01980706)
NCT ID: NCT01980706
Last Updated: 2019-06-12
Results Overview
The frequency of heavy drinking days (5 or more drinks for a man and 4 or more drinks for a woman) as percentage during the treatment phase.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Every 1-2 weeks up to 16 weeks of active trial
Results posted on
2019-06-12
Participant Flow
Participant milestones
| Measure |
Placebo
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a gamma-aminobutyric acid (GABA)-B receptor agonist
|
90 mg Baclofen
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
43
|
37
|
|
Overall Study
COMPLETED
|
23
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
13
|
Reasons for withdrawal
| Measure |
Placebo
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a gamma-aminobutyric acid (GABA)-B receptor agonist
|
90 mg Baclofen
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
9
|
6
|
2
|
|
Overall Study
Adverse Event
|
1
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
3
|
|
Overall Study
miscellaneous
|
4
|
5
|
3
|
Baseline Characteristics
Not all subjects had CDT analyzed.
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=43 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=37 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.1 years
STANDARD_DEVIATION 9.6 • n=40 Participants
|
46.1 years
STANDARD_DEVIATION 10.4 • n=43 Participants
|
44.8 years
STANDARD_DEVIATION 10.3 • n=37 Participants
|
46.0 years
STANDARD_DEVIATION 10.1 • n=120 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=40 Participants
|
21 Participants
n=43 Participants
|
17 Participants
n=37 Participants
|
58 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=40 Participants
|
22 Participants
n=43 Participants
|
20 Participants
n=37 Participants
|
62 Participants
n=120 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=40 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=40 Participants
|
1 Participants
n=43 Participants
|
1 Participants
n=37 Participants
|
2 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=40 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=40 Participants
|
5 Participants
n=43 Participants
|
6 Participants
n=37 Participants
|
14 Participants
n=120 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=40 Participants
|
36 Participants
n=43 Participants
|
30 Participants
n=37 Participants
|
102 Participants
n=120 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=40 Participants
|
1 Participants
n=43 Participants
|
0 Participants
n=37 Participants
|
1 Participants
n=120 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=40 Participants
|
0 Participants
n=43 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=120 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=40 Participants
|
43 Participants
n=43 Participants
|
37 Participants
n=37 Participants
|
120 Participants
n=120 Participants
|
|
Baseline Percentage of Heavy Drinking Days
|
79 percentage of heavy drinking days
STANDARD_DEVIATION 21 • n=40 Participants
|
73 percentage of heavy drinking days
STANDARD_DEVIATION 23 • n=43 Participants
|
70 percentage of heavy drinking days
STANDARD_DEVIATION 26 • n=37 Participants
|
74 percentage of heavy drinking days
STANDARD_DEVIATION 23 • n=120 Participants
|
|
Baseline Percentage of Abstinent Days
|
13 Percentage of Abstinent Days
STANDARD_DEVIATION 17 • n=40 Participants
|
17 Percentage of Abstinent Days
STANDARD_DEVIATION 19 • n=43 Participants
|
18 Percentage of Abstinent Days
STANDARD_DEVIATION 20 • n=37 Participants
|
16 Percentage of Abstinent Days
STANDARD_DEVIATION 19 • n=120 Participants
|
|
Baseline Drinks/drinking day
|
9.3 drinks per drinking day
STANDARD_DEVIATION 3.9 • n=40 Participants
|
10.7 drinks per drinking day
STANDARD_DEVIATION 7.7 • n=43 Participants
|
10.0 drinks per drinking day
STANDARD_DEVIATION 4.2 • n=37 Participants
|
10.0 drinks per drinking day
STANDARD_DEVIATION 5.6 • n=120 Participants
|
|
Goal of Abstinence
|
16 Participants
n=40 Participants
|
24 Participants
n=43 Participants
|
12 Participants
n=37 Participants
|
52 Participants
n=120 Participants
|
|
Craving for Alcohol
|
14.5 units on a scale
STANDARD_DEVIATION 6.8 • n=40 Participants
|
15.5 units on a scale
STANDARD_DEVIATION 7.2 • n=43 Participants
|
15.3 units on a scale
STANDARD_DEVIATION 6.1 • n=37 Participants
|
15.1 units on a scale
STANDARD_DEVIATION 6.7 • n=120 Participants
|
|
Carbohydrate Deficient Transferrin (CDT)
|
2.31 % CDT
STANDARD_DEVIATION 1.95 • n=38 Participants • Not all subjects had CDT analyzed.
|
1.72 % CDT
STANDARD_DEVIATION 0.63 • n=40 Participants • Not all subjects had CDT analyzed.
|
2.22 % CDT
STANDARD_DEVIATION 1.46 • n=35 Participants • Not all subjects had CDT analyzed.
|
2.07 % CDT
STANDARD_DEVIATION 1.46 • n=113 Participants • Not all subjects had CDT analyzed.
|
|
Speilberger State Anxiety
|
35.0 units on a scale
STANDARD_DEVIATION 10.5 • n=40 Participants
|
36.3 units on a scale
STANDARD_DEVIATION 12.4 • n=43 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 9.7 • n=37 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 10.9 • n=120 Participants
|
PRIMARY outcome
Timeframe: Every 1-2 weeks up to 16 weeks of active trialPopulation: Post-randomization data were unavailable for 2 participants.
The frequency of heavy drinking days (5 or more drinks for a man and 4 or more drinks for a woman) as percentage during the treatment phase.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=42 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=36 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Mean Percentage of Heavy Drinking Days
|
39 percentage of heavy drinking days
Standard Error 4
|
42 percentage of heavy drinking days
Standard Error 4
|
28 percentage of heavy drinking days
Standard Error 4
|
PRIMARY outcome
Timeframe: Every 1-2 weeks up to 16 weeks of active trialPopulation: Post-randomization data were unavailable for 2 participants.
Percent of abstinent days over the course of the trial.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=42 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=36 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Mean Percentage of Abstinent Drinking Days
|
47 percentage of days
Standard Error 4
|
48 percentage of days
Standard Error 4
|
59 percentage of days
Standard Error 4
|
SECONDARY outcome
Timeframe: Every 1-2 weeks up to 16 weeks of active trialThe Spielberger State and Trait Anxiety Inventory (STAI) is a validated self-reporting instrument used to assess anxiety in adults.The inventory consists of state anxiety, which evaluates how the subject feels currently (transient anxiety). The State scale consists of 20 questions, each question rated 1-4, and a higher score indicates greater anxiety. Total score ranges from 20 (no anxiety) to 80 (maximum anxiety). The scores are averaged over the trial.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=43 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=37 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Mean Spielberger State-Trait Anxiety Inventory Score [State]
|
35.2 units on a scale
Standard Error 1.16
|
33.8 units on a scale
Standard Error 1.12
|
33.6 units on a scale
Standard Error 1.18
|
SECONDARY outcome
Timeframe: Every 1-2 weeks up to 16 weeks of active trialPenn Alcohol Craving Scale (PACS) is a five-item self administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking as well as the ability to resist drinking. Scores range from a minimum of zero to a maximum of 30. Lower scores are associated with lower level of craving for alcohol. Scores are averaged over the trial.
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=43 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=37 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Mean Penn Alcohol Craving Scale Score
|
10.1 units on a scale
Standard Error 0.91
|
10.8 units on a scale
Standard Error 0.88
|
9.4 units on a scale
Standard Error 0.92
|
SECONDARY outcome
Timeframe: End of trial, generally 16 weeksPopulation: Post-randomization CDT was not collected for all participants.
Lab test assessing history of heavy drinking with greater specificity than GGT. Higher levels are indicative of greater levels of drinking.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=20 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=17 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Carbohydrate-deficient Transferrin
|
1.81 % CDT
Standard Error .26
|
2.19 % CDT
Standard Error .26
|
1.96 % CDT
Standard Error .28
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 1-2 weeks up to 16 weeks of active trialPopulation: Post-randomization data were unavailable for 2 participants.
Any reporting of feeling sedated/sleepy/drowsy
Outcome measures
| Measure |
Placebo
n=40 Participants
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=42 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=36 Participants
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Self-reported Sedation on at Least One Occasion by a Participant
|
14 Participants
|
25 Participants
|
20 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
30 Mg Baclofen
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
90 mg Baclofen
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=40 participants at risk
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=43 participants at risk
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=37 participants at risk
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Nervous system disorders
Drowsiness
|
0.00%
0/40 • Throughout treatment and for 4 weeks after treatment ended.
|
0.00%
0/43 • Throughout treatment and for 4 weeks after treatment ended.
|
2.7%
1/37 • Number of events 1 • Throughout treatment and for 4 weeks after treatment ended.
|
Other adverse events
| Measure |
Placebo
n=40 participants at risk
Participants will take placebo for 16 weeks, 3 times per day. Placebo will be given in blister packs.
Placebo: Pill containing no pharmacologically active substance.
|
30 Mg Baclofen
n=43 participants at risk
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 30 mg/d arm will reach 30 mg/d at day 3 and titrate down starting at day 101.
Baclofen: Baclofen is a GABA-B agonist
|
90 mg Baclofen
n=37 participants at risk
Participants will take baclofen/placebo for 16 weeks, 3 times per day. Baclofen will be given in blister packs. The 90 mg/d arm will reach 90 mg/d at day 12 and titrate down starting at day 95.
Baclofen: Baclofen is a GABA-B agonist
|
|---|---|---|---|
|
Nervous system disorders
Sedation
|
35.0%
14/40 • Throughout treatment and for 4 weeks after treatment ended.
|
58.1%
25/43 • Throughout treatment and for 4 weeks after treatment ended.
|
54.1%
20/37 • Throughout treatment and for 4 weeks after treatment ended.
|
|
Nervous system disorders
Dizziness
|
12.5%
5/40 • Throughout treatment and for 4 weeks after treatment ended.
|
27.9%
12/43 • Throughout treatment and for 4 weeks after treatment ended.
|
21.6%
8/37 • Throughout treatment and for 4 weeks after treatment ended.
|
|
Skin and subcutaneous tissue disorders
Itchiness/rash
|
10.0%
4/40 • Throughout treatment and for 4 weeks after treatment ended.
|
18.6%
8/43 • Throughout treatment and for 4 weeks after treatment ended.
|
0.00%
0/37 • Throughout treatment and for 4 weeks after treatment ended.
|
|
General disorders
Fatigue/low energy
|
5.0%
2/40 • Throughout treatment and for 4 weeks after treatment ended.
|
11.6%
5/43 • Throughout treatment and for 4 weeks after treatment ended.
|
5.4%
2/37 • Throughout treatment and for 4 weeks after treatment ended.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • Throughout treatment and for 4 weeks after treatment ended.
|
11.6%
5/43 • Throughout treatment and for 4 weeks after treatment ended.
|
10.8%
4/37 • Throughout treatment and for 4 weeks after treatment ended.
|
|
Gastrointestinal disorders
Constipation
|
7.5%
3/40 • Throughout treatment and for 4 weeks after treatment ended.
|
9.3%
4/43 • Throughout treatment and for 4 weeks after treatment ended.
|
5.4%
2/37 • Throughout treatment and for 4 weeks after treatment ended.
|
|
General disorders
Headache
|
7.5%
3/40 • Throughout treatment and for 4 weeks after treatment ended.
|
11.6%
5/43 • Throughout treatment and for 4 weeks after treatment ended.
|
10.8%
4/37 • Throughout treatment and for 4 weeks after treatment ended.
|
Additional Information
James C Garbutt, MD
University of North Carolina at Chapel Hill
Phone: 984-974-2201
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place