Trial Outcomes & Findings for Baclofen Effects on Smoking Urge and Withdrawal (NCT NCT00257894)

Results Overview

Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge). These data are only available on the subset of participants who participated through Day 10.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.

Results posted on

2015-11-04

Participant Flow

Participants were veterans recruited from the Veterans Affairs Medical Center, Veterans Affairs Medical Center staff, visitors, and smokers recruited from the community.

Nine people washed out or failed to return before assignment to groups, or were assessed with an invalid informed consent so the IRB required their data to be excluded from all analyses, and no demographic information is available on these people, leaving n = 32 with at least age and gender.

Participant milestones

Participant milestones
Measure	Baclofen Condition Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.	Placebo Condition Placebo capsules identical to active medication, 3/day for 12 days.
Overall Study STARTED	21	20
Overall Study COMPLETED	17	15
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baclofen Effects on Smoking Urge and Withdrawal

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baclofen Condition n=17 Participants Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.	Placebo Condition n=15 Participants Placebo capsules identical to active medication, 3/day for 12 days.	Total n=32 Participants Total of all reporting groups
Age, Continuous	47.4 years STANDARD_DEVIATION 10.7 • n=5 Participants	43.5 years STANDARD_DEVIATION 9.8 • n=7 Participants	45.6 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	8 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants
Fagerstrom Test for Nicotine Dependence	6.18 units on a scale STANDARD_DEVIATION 1.59 • n=5 Participants	5.93 units on a scale STANDARD_DEVIATION 2.76 • n=7 Participants	6.06 units on a scale STANDARD_DEVIATION 2.18 • n=5 Participants
Number of cigarettes smoked per day	20.4 cigarettes STANDARD_DEVIATION 7.6 • n=5 Participants	19.0 cigarettes STANDARD_DEVIATION 8.1 • n=7 Participants	19.7 cigarettes STANDARD_DEVIATION 7.8 • n=5 Participants
Number of years smoked daily	28.5 years STANDARD_DEVIATION 11.9 • n=5 Participants	24.9 years STANDARD_DEVIATION 11.7 • n=7 Participants	26.9 years STANDARD_DEVIATION 11.7 • n=5 Participants

PRIMARY outcome

Timeframe: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.

Questionnaire of Smoking Urges assesses cravings to smoke. the score is the mean of 10 7-point Likert ratings so the range of the total score is from 1 (no urge) to 7 (intense urge). These data are only available on the subset of participants who participated through Day 10.

Outcome measures

Outcome measures
Measure	Baclofen Condition n=16 Participants Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.	Placebo Condition n=11 Participants Placebo capsules identical to active medication, 3/day for 12 days.
Total Score on Questionnaire of Smoking Urges	5.5 units on a scale Standard Deviation 2.1	5.3 units on a scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: Day 10

Measure of degree of nicotine withdrawal at the time. Scored as the mean of 8 5-point ratings so the total score ranges from 0 (no withdrawal) to 4 (severe withdrawal). These data are only available on the subset of participants who participated through Day 10.

Outcome measures

Outcome measures
Measure	Baclofen Condition n=16 Participants Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.	Placebo Condition n=12 Participants Placebo capsules identical to active medication, 3/day for 12 days.
Minnesota Nicotine Withdrawal Questionnaire	1.06 units on a scale Standard Deviation 1.73	1.58 units on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: Measures are assessed on the tenth day of medication titration, after 5 hours of smoking deprivation.

Expired carbon monoxide (CO) assessed before and after a 2.5-h period when they make choices for cigarette puffs versus money. CO Boost is the difference score, possibly ranging from -25 (improved) to +25 (worse). These data are only available on the subset of participants who participated through Day 10..

Outcome measures

Outcome measures
Measure	Baclofen Condition n=16 Participants Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.	Placebo Condition n=11 Participants Placebo capsules identical to active medication, 3/day for 12 days.
Nicotine Self-administration as Quantified by Carbon Monoxide Boost During a Behavioral Self-administration Task.	4.69 units on a scale Standard Deviation 4.16	5.27 units on a scale Standard Deviation 5.90

SECONDARY outcome

Timeframe: Tenth day of medication titration

At 20 times spaced over a 2.5 h period, participants chose between smoking two puffs (of pre-determined size) of a cigarette and receiving US$0.10. The primary behavioral outcome measure was number of cigarette choices, ranging from 0 (no smoking) to 20 (smoking the most allowed). These data are only available on the subset of participants who participated through Day 10.

Outcome measures

Outcome measures
Measure	Baclofen Condition n=16 Participants Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.	Placebo Condition n=11 Participants Placebo capsules identical to active medication, 3/day for 12 days.
Cigarette Choice Task	15.4 choices Standard Deviation 5.7	18.2 choices Standard Deviation 4.8

Adverse Events

Baclofen Condition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Condition

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Baclofen Condition n=21 participants at risk Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.	Placebo Condition n=20 participants at risk Placebo capsules identical to active medication, 3/day for 12 days.
Musculoskeletal and connective tissue disorders Hospitalization	0.00% 0/21 • 1 year 11 months Jan. 2007 - Nov. 2008	5.0% 1/20 • Number of events 1 • 1 year 11 months Jan. 2007 - Nov. 2008

Other adverse events

Adverse event data not reported

Additional Information

Damaris J. Rohsenow, Ph.D.

Veterans Affairs Medical Center (VAMC), Providence

Phone: 401-863-6648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place