Trial Outcomes & Findings for Does CERC-501 Attenuate Stress-precipitated Smoking Lapse? (NCT NCT02800928)

NCT ID: NCT02800928

Last Updated: 2019-08-13

Results Overview

Latency (in minutes and seconds) to time of first cigarette smoking during the delay period

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: 50 min
• Results posted on: 2019-08-13

Participant Flow

This is a cross-over design. Medication arms are within-subject.

Participant milestones

Measure	Treatment First Administered orally once daily, 10mg daily, 8 days CERC-501: CERC-501 7 day wash-out Administered orally once daily, placebo, 8 days Order of placebo/CERC-501 counterbalanced	Placebo First Administered orally once daily, placebo, 8 days FIRST 7 day wash-out Administered orally once daily, CERC-501: CERC-501 10mg daily, 8 days SECOND
Overall Study STARTED	9	8
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Treatment First Administered orally once daily, 10mg daily, 8 days CERC-501: CERC-501 7 day wash-out Administered orally once daily, placebo, 8 days Order of placebo/CERC-501 counterbalanced	Placebo First Administered orally once daily, placebo, 8 days FIRST 7 day wash-out Administered orally once daily, CERC-501: CERC-501 10mg daily, 8 days SECOND
Overall Study Withdrawal by Subject	1	1
Overall Study Protocol Violation	1	1

Baseline Characteristics

Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?

Baseline characteristics by cohort

Measure	All Study Participants n=17 Participants Administered orally once daily, 10mg daily, 8 days CERC-501: CERC-501 7 day wash-out Administered orally once daily, placebo Order of placebo/CERC-501 counterbalanced
Age, Continuous	35.18 years STANDARD_DEVIATION 8.13 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Cigarettes per day	16.24 cigarettes per day STANDARD_DEVIATION 3.90 • n=5 Participants

PRIMARY outcome

Timeframe: 50 min

Population: 13 subjects completed study (i.e., completed both CERC-501 and Placebo periods in this cross over design).

Latency (in minutes and seconds) to time of first cigarette smoking during the delay period

Outcome measures

Measure	CERC-501 n=13 Participants Administered orally once daily, 10mg daily, 8 days CERC-501: CERC-501	Placebo n=13 Participants Administered orally daily, 8 days Placebo: Placebo
Latency	24.56 minutes Standard Error 6.40	26.64 minutes Standard Error 6.62

PRIMARY outcome

Timeframe: 60 min

Number of cigarettes smoked during the self administration period

Outcome measures

Measure	CERC-501 n=13 Participants Administered orally once daily, 10mg daily, 8 days CERC-501: CERC-501	Placebo n=13 Participants Administered orally daily, 8 days Placebo: Placebo
Number of Cigarettes Smoked	1.67 number of cigarettes Standard Error 0.28	1.92 number of cigarettes Standard Error 0.25

Adverse Events

CERC-501

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CERC-501 n=16 participants at risk Administered orally once daily, 10mg daily, 8 days CERC-501: CERC-501	Placebo n=15 participants at risk Administered orally daily, 8 days Placebo: Placebo
General disorders headache	0.00% 0/16 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.	13.3% 2/15 • Number of events 2 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.
Gastrointestinal disorders constipation	6.2% 1/16 • Number of events 1 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.	0.00% 0/15 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.
Gastrointestinal disorders Diarrhea	6.2% 1/16 • Number of events 1 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.	0.00% 0/15 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.
General disorders insomnia	6.2% 1/16 • Number of events 1 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.	0.00% 0/15 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.
Skin and subcutaneous tissue disorders pruritus	6.2% 1/16 • Number of events 1 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.	0.00% 0/15 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.
Gastrointestinal disorders nausea	0.00% 0/16 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.	6.7% 1/15 • Number of events 1 • 8 days SAFTEE assessment. In total 16 subjects were exposed to CERC-501 and are included in adverse event analysis. In total 15 subjects were exposed to placebo and are included in the adverse event analysis. This is a cross-over design.

Additional Information

Sherry McKee PhD

Yale School of Medicine

Phone: 203-737-3529

Email: sherry.mckee@yale.edu

Results disclosure agreements

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