Trial Outcomes & Findings for Guanfacine Clinical Trial for Smoking Cessation (NCT NCT02051309)

NCT ID: NCT02051309

Last Updated: 2021-12-29

Results Overview

Prolonged smoking abstinence defined as no relapse in week 3 to week 8, in participants with available outcome data during weeks 3 to 8.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 121 participants
• Primary outcome timeframe: Week 3 to week 8 during 8-week treatment phase
• Results posted on: 2021-12-29

Participant Flow

Participant milestones

Measure	Guanfacine 6mg/Day ER Guanfacine 6mg/day extended release Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication.	Placebo Placebo matching capsule Placebo
Overall Study STARTED	58	63
Overall Study COMPLETED	26	35
Overall Study NOT COMPLETED	32	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Guanfacine Clinical Trial for Smoking Cessation

Baseline characteristics by cohort

Measure	Guanfacine 6mg/Day ER n=58 Participants Guanfacine 6mg/day extended release Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication.	Placebo n=63 Participants Placebo matching capsule Placebo	Total n=121 Participants Total of all reporting groups
Age, Continuous	48.17 years STANDARD_DEVIATION 11.70 • n=5 Participants	47.68 years STANDARD_DEVIATION 11.42 • n=7 Participants	47.91 years STANDARD_DEVIATION 11.55 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	33 Participants n=7 Participants	61 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	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants	46 Participants n=7 Participants	88 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Cigarettes per day	18.21 cigarettes per day STANDARD_DEVIATION 7.67 • n=5 Participants	18.32 cigarettes per day STANDARD_DEVIATION 8.66 • n=7 Participants	18.26 cigarettes per day STANDARD_DEVIATION 8.19 • n=5 Participants

PRIMARY outcome

Timeframe: Week 3 to week 8 during 8-week treatment phase

Population: Participants with available outcome data during weeks 3 to 8.

Prolonged smoking abstinence defined as no relapse in week 3 to week 8, in participants with available outcome data during weeks 3 to 8.

Outcome measures

Measure	Guanfacine 6mg/Day ER n=31 Participants Guanfacine 6mg/day extended release Guanfacine: 6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication.	Placebo n=40 Participants Placebo matching capsule Placebo
Rates of Prolonged Smoking Abstinence	11 Participants	7 Participants

Adverse Events

Guanfacine 6mg/Day ER

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sherry McKee PhD

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