Trial Outcomes & Findings for Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention (NCT NCT01188967)

Last Updated: 2017-02-23

Results Overview

The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 4-week, continuous tobacco abstinence than those assigned to identical placebo at the end of the 6-week, double blind, treatment phase. Four-week continuous abstinence will be defined as Timeline Followback Calendar confirmation at study visit of smoking no cigarettes in the past 7 days, and expired air CO\<10ppm for 4 consecutive weeks (the last 4 weeks of the randomized phase)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

Week 8 of the study

Results posted on

2017-02-23

Participant Flow

84 participants signed consent and 40 of those participants were found ineligible. 11 participants voluntarily withdrew consent. 4 participants were terminated by the investigator for reasons other than toxicity/adverse events (ie noncompliance). 11 participants were lost to follow up.

Participant milestones

Participant milestones
Measure	GSK598809 Treatment Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received 60 mg GSK598809 pills, the active treatment, for 6 weeks.	Placebo Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
Overall Study STARTED	10	8
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK598809 Treatment Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received 60 mg GSK598809 pills, the active treatment, for 6 weeks.	Placebo Group There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
Overall Study Withdrawal by Subject	1	1
Overall Study Physician Decision	1	1
Overall Study Lost to Follow-up	3	2

Baseline Characteristics

Effectiveness of GSK598809, a Selective D3 Antagonist, Added to CBT and NRT for Smoking Cessation and Relapse Prevention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Treatment Group n=8 Participants There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received placebo pills.	GSK598809 Treatment Group n=10 Participants There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received the active treatment: GSK598809 pills,60 mg/day.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48.7 years STANDARD_DEVIATION 5 • n=5 Participants	46.7 years STANDARD_DEVIATION 5 • n=7 Participants	47.7 years STANDARD_DEVIATION 5 • n=5 Participants
Gender Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Gender Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	10 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 8 of the study

Population: 9 participants completed this visit

Outcome measures

Outcome measures
Measure	Placebo Treatment Group n=4 Participants	GSK598809 Treatment Group n=5 Participants
4-week, Continuous Tobacco Abstinence at the End of the 6-week, Double Blind, Treatment Phase	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 3 of the study

Population: 13 participants completed week 1 visit

Outcome measures

Outcome measures
Measure	Placebo Treatment Group n=6 Participants	GSK598809 Treatment Group n=7 Participants
7-day, Point-prevalence Tobacco Abstinence at the End of the First Week of Exposure to GSK598809/Placebo	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 8 of the study

Population: 7 participants completed week 6 weeks exposure to GSK598809/placebo.

Outcome measures

Outcome measures
Measure	Placebo Treatment Group n=4 Participants	GSK598809 Treatment Group n=5 Participants
7-day, Point-prevalence Tobacco Abstinence at the End of 6 Weeks Exposure to GSK598809/Placebo	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 10 of the study

Population: 7 participants completed this visit.

The hypothesis is that those assigned to GSK598809 will demonstrate a higher rate of biochemically-verified, 7-day, point-prevalence tobacco abstinence than those assigned to identical placebo two weeks after discontinuation of double blind study medications. 7-day, Point-prevalence tobacco abstinence was defined as not smoking for the 7 consecutive days before this visit after discontinuation of double blind study medications

Outcome measures

Outcome measures
Measure	Placebo Treatment Group n=3 Participants	GSK598809 Treatment Group n=4 Participants
Number of Participants With 7-day, Point-prevalence Tobacco Abstinence 2-weeks After Discontinuation of Double Blind Study Medications	0 Participants	0 Participants

Adverse Events

Placebo Treatment Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

GSK598809 Treatment Group

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Treatment Group n=8 participants at risk There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the placebo pills.	GSK598809 Treatment Group n=10 participants at risk There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the GSK598809 pills, the active treatment.
Infections and infestations Anal abscess	0.00% 0/8 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	10.0% 1/10 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.

Other adverse events

Other adverse events
Measure	Placebo Treatment Group n=8 participants at risk There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the placebo pills.	GSK598809 Treatment Group n=10 participants at risk There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the GSK598809 pills, the active treatment.
General disorders Leg Cramps	12.5% 1/8 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	0.00% 0/10 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Tiredness	12.5% 1/8 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	0.00% 0/10 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Fungal Skin Infection	0.00% 0/8 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	10.0% 1/10 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
Renal and urinary disorders Urinary Dysuria	12.5% 1/8 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	0.00% 0/10 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Headache	25.0% 2/8 • Number of events 2 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	10.0% 1/10 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Peripheral Vascular Disease	0.00% 0/8 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	10.0% 1/10 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Weight Gain	12.5% 1/8 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	0.00% 0/10 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Dry Tongue	0.00% 0/8 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	10.0% 1/10 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Numbness of Tongue	0.00% 0/8 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	10.0% 1/10 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Chest Tightness	0.00% 0/8 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	10.0% 1/10 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
Skin and subcutaneous tissue disorders Eczema Flame	12.5% 1/8 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	0.00% 0/10 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Insomnia	12.5% 1/8 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	0.00% 0/10 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
Renal and urinary disorders URI	25.0% 2/8 • Number of events 2 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	10.0% 1/10 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.
General disorders Cold	12.5% 1/8 • Number of events 1 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.	0.00% 0/10 • Adverse event data was collected for the duration of the study, 10 weeks in total (2 weeks before quitting, 6 weeks on double blind GSK598809 or placebo, 2 weeks of follow up). Adverse events were recorded for all subjects at weekly sessions.

Additional Information

Maurizio Fava M.D.

Massachusetts General Hospital

Phone: 617-724-2513

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60