Trial Outcomes & Findings for Baclofen Effects in Cigarette Smokers (NCT NCT01821560)
NCT ID: NCT01821560
Last Updated: 2018-12-19
Results Overview
Cigarettes per day at Scan Day 2; Baclofen group vs. placebo group
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
44 participants
Primary outcome timeframe
3 weeks (Scan Day 1, week1- Scan Day 2, week 4)
Results posted on
2018-12-19
Participant Flow
Participants were recruitment between March 2013-March 2017 via word of mouth, flyers, an online study database managed by the University of Pennsylvania, and also social media advertisements (Facebook).
Prior to study group assignments, all participants must first provide informed consent and then are found to be eligible to participate in the study after completing the screening process. The screening process included a full physical and psychological evaluation to ensure all participants are both physically and mentally healthy enough.
Participant milestones
| Measure |
Sugar Pill
Placebo-treated subjects will follow the identical schedule as Baclofen subjects.
placebo
|
Baclofen
Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.
Baclofen
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Sugar Pill
Placebo-treated subjects will follow the identical schedule as Baclofen subjects.
placebo
|
Baclofen
Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.
Baclofen
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Baclofen Effects in Cigarette Smokers
Baseline characteristics by cohort
| Measure |
Sugar Pill
n=22 Participants
Placebo-treated subjects will follow the identical schedule as Baclofen subjects.
placebo
|
Baclofen
n=22 Participants
Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.
Baclofen
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.2 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
38.9 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
39.5 Years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White Non-Hispanic
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Mixed Race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White Hispanic
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeks (Scan Day 1, week1- Scan Day 2, week 4)Cigarettes per day at Scan Day 2; Baclofen group vs. placebo group
Outcome measures
| Measure |
Sugar Pill
n=22 Participants
Placebo-treated subjects will follow the identical schedule as Baclofen subjects.
placebo
|
Baclofen
n=22 Participants
Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.
Baclofen
|
|---|---|---|
|
Cigarettes Smoked Per Day
Scan Day 1
|
14.19 Cigarettes per day
Standard Error 1.01
|
14.23 Cigarettes per day
Standard Error 1.20
|
|
Cigarettes Smoked Per Day
Scan Day 2
|
7.67 Cigarettes per day
Standard Error 1.05
|
7.76 Cigarettes per day
Standard Error 1.10
|
Adverse Events
Sugar Pill
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Baclofen
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sugar Pill
n=22 participants at risk
Placebo-treated subjects will follow the identical schedule as Baclofen subjects.
placebo
|
Baclofen
n=22 participants at risk
Baclofen will be dispensed in pill form. Baclofen will be prescribed at 20 mg 4 times per day. Each baclofen pill will be 10 mg. Thus, 2 pills will be taken at each scheduled dose for a total of 8 pills a day over a period of 8 weeks. In this way, the titration schedule, taper and potential dose reductions can be managed.
Baclofen
|
|---|---|---|
|
Nervous system disorders
Drowsiness
|
27.3%
6/22 • Collected over a 5 year period
|
40.9%
9/22 • Collected over a 5 year period
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Collected over a 5 year period
|
18.2%
4/22 • Collected over a 5 year period
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • Collected over a 5 year period
|
9.1%
2/22 • Collected over a 5 year period
|
|
Nervous system disorders
Dizzy/Lightheadedness
|
4.5%
1/22 • Collected over a 5 year period
|
22.7%
5/22 • Collected over a 5 year period
|
|
Nervous system disorders
Insomnia
|
4.5%
1/22 • Collected over a 5 year period
|
9.1%
2/22 • Collected over a 5 year period
|
|
Nervous system disorders
Cognitive Changes
|
9.1%
2/22 • Collected over a 5 year period
|
18.2%
4/22 • Collected over a 5 year period
|
|
Psychiatric disorders
Affective Changes
|
0.00%
0/22 • Collected over a 5 year period
|
18.2%
4/22 • Collected over a 5 year period
|
|
Vascular disorders
Elevated Blood Pressure
|
4.5%
1/22 • Collected over a 5 year period
|
13.6%
3/22 • Collected over a 5 year period
|
|
Gastrointestinal disorders
Digestive
|
18.2%
4/22 • Collected over a 5 year period
|
18.2%
4/22 • Collected over a 5 year period
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal
|
0.00%
0/22 • Collected over a 5 year period
|
9.1%
2/22 • Collected over a 5 year period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place