Trial Outcomes & Findings for Modeling Stress-precipitated Smoking Behavior for Medication Development (NCT NCT00773357)

NCT ID: NCT00773357

Last Updated: 2022-08-03

Results Overview

latency to initiate smoking (in minutes) during a 50-minute period.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 100 participants
• Primary outcome timeframe: 50 minutes
• Results posted on: 2022-08-03

Participant Flow

Participant milestones

Measure	Guanfacine guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.	Placebo placebo control placebo: placebo
Overall Study STARTED	50	50
Overall Study COMPLETED	50	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Modeling Stress-precipitated Smoking Behavior for Medication Development

Baseline characteristics by cohort

Measure	Guanfacine n=50 Participants guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.	Placebo n=50 Participants placebo control placebo: placebo	Total n=100 Participants Total of all reporting groups
Age, Continuous	35.36 years STANDARD_DEVIATION 10.05 • n=5 Participants	36.92 years STANDARD_DEVIATION 11.73 • n=7 Participants	36.14 years STANDARD_DEVIATION 10.89 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	22 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	18 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	28 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants
Cigarettes per day	15.44 cigarettes per day STANDARD_DEVIATION 7.58 • n=5 Participants	15.12 cigarettes per day STANDARD_DEVIATION 8.11 • n=7 Participants	15.28 cigarettes per day STANDARD_DEVIATION 7.845 • n=5 Participants

PRIMARY outcome

Timeframe: 50 minutes

latency to initiate smoking (in minutes) during a 50-minute period.

Outcome measures

Measure	Guanfacine n=50 Participants guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.	Placebo n=50 Participants placebo control placebo: placebo
Latency to Initiate Ad-lib Smoking Session	31.55 minutes Standard Error 5.30	30.31 minutes Standard Error 5.44

Adverse Events

Guanfacine

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Guanfacine n=50 participants at risk guanfacine 3mg/day guanfacine: 3 mg/day, with 3-week lead-in medication period. The starting dose is 0.5 mg/day for days 1-3, followed by 1.5mg/day for days 4-7, followed by 2 mg/day for days 8-12, followed by 2.5 mg/day for days 13-15, followed by 3 mg/day from day 16 to remainder of study. 5-day taper at end of study.	Placebo n=50 participants at risk placebo control placebo: placebo
General disorders dry mouth	70.0% 35/50 • Titration period of 21 days	24.0% 12/50 • Titration period of 21 days
General disorders Drowsiness	38.0% 19/50 • Titration period of 21 days	18.0% 9/50 • Titration period of 21 days
Nervous system disorders Dizziness	10.0% 5/50 • Titration period of 21 days	8.0% 4/50 • Titration period of 21 days
Nervous system disorders Headache	30.0% 15/50 • Titration period of 21 days	20.0% 10/50 • Titration period of 21 days
Reproductive system and breast disorders Impotence	2.0% 1/50 • Titration period of 21 days	2.0% 1/50 • Titration period of 21 days
Gastrointestinal disorders Constipation	20.0% 10/50 • Titration period of 21 days	12.0% 6/50 • Titration period of 21 days
General disorders Fatigue	36.0% 18/50 • Titration period of 21 days	4.0% 2/50 • Titration period of 21 days

Additional Information

Sherry McKee

Yale School of Medicine

Phone: 2037373529

Email: sherry.mckee@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place