Trial Outcomes & Findings for Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1 (NCT NCT03507127)

NCT ID: NCT03507127

Last Updated: 2022-05-17

Results Overview

Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher levels of smoking urge or craving.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: 72 hrs abstinence
• Results posted on: 2022-05-17

Participant Flow

Participant milestones

Measure	Varenicline Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Overall Study STARTED	3	2
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Varenicline Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Overall Study Withdrawal by Subject	1	0
Overall Study Unable to meet smoking abstinence criterion	1	1

Baseline Characteristics

Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1

Baseline characteristics by cohort

Measure	Varenicline n=3 Participants Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=2 Participants Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.	Total n=5 Participants Total of all reporting groups
Age, Continuous	52.7 years STANDARD_DEVIATION 8.5 • n=5 Participants	46 years STANDARD_DEVIATION 7.1 • n=7 Participants	50 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Fagerstrom Test of Nicotine Dependence score	8.3 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	6.5 units on a scale STANDARD_DEVIATION 0.7 • n=7 Participants	7.6 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants

PRIMARY outcome

Timeframe: 72 hrs abstinence

Average of all items, rated from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher levels of smoking urge or craving.

Outcome measures

Measure	Varenicline n=3 Participants Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=2 Participants Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Questionnaire on Smoking Urges - Brief Form	3.12 score on a scale Standard Deviation 2.11	4.41 score on a scale Standard Deviation 2.72

PRIMARY outcome

Timeframe: 72 hrs abstinence

Average of responses to the anger, depression, anxiety and difficulty concentrating items, which are rated from 0 (not present) to 4 (severe).

Outcome measures

Measure	Varenicline n=3 Participants Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=2 Participants Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Minnesota Nicotine Withdrawal Scale - Negative Affect Scale	1.45 score on a scale Standard Deviation 0.57	0.85 score on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: 72 hrs abstinence

Average of the satisfaction, taste and enjoyment items, which are rated from 1 (not at all) to 7 (extremely)

Outcome measures

Measure	Varenicline n=3 Participants Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=2 Participants Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Modified Cigarette Evaluation Questionnaire - Satisfaction Scale	5.33 score on a scale Standard Deviation 1.15	3.43 score on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: 72 hrs abstinence

Average of the calm, feel more awake, less irritable, help to concentrate and reduce hunger items, which are rated from 1 (not at all) to 7 (extremely)

Outcome measures

Measure	Varenicline n=3 Participants Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=2 Participants Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Modified Cigarette Evaluation Questionnaire - Reward Scale	4.00 score on a scale Standard Deviation 0.35	4.30 score on a scale Standard Deviation 0.0

SECONDARY outcome

Timeframe: 1 week

hours until relapse during a smoking abstinence period, verified with breath carbon monoxide (CO) levels

Outcome measures

Measure	Varenicline n=1 Participants Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=1 Participants Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Latency to Smoking Relapse	8 hours Standard Deviation 0	24 hours Standard Deviation 0

OTHER_PRE_SPECIFIED outcome

Timeframe: 72 hrs abstinence

Sum of all items rated from 1 (not present) to 7 (extremely severe)

Outcome measures

Measure	Varenicline n=3 Participants Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=2 Participants Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Brief Psychiatric Rating Scale	1.33 score on a scale Standard Deviation 0.11	1.37 score on a scale Standard Deviation 0.06

Adverse Events

Varenicline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Varenicline n=3 participants at risk Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=2 participants at risk Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Psychiatric disorders voluntary psychiatric hospitalization	0.00% 0/3 • 19 days	50.0% 1/2 • Number of events 1 • 19 days

Other adverse events

Measure	Varenicline n=3 participants at risk Varenicline: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.	Placebo n=2 participants at risk Placebo: Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • 19 days	0.00% 0/2 • 19 days

Additional Information

Dr. Jennifer Tidey

Brown University

Phone: 4018636418

Email: jennifer_tidey@brown.edu

Results disclosure agreements

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