Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?

Phase 2

Completed

• Conditions: Smoking
• Interventions: Drug: CERC-501; Drug: Placebo

• Registration Number: NCT02800928
• Lead Sponsor: Yale University

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Stress-precipitated Smoking Behavior.

Detailed Description

The study will be performed in subjects who are heavy cigarette smokers currently not seeking treatment for tobacco use disorder.

The study is a crossover design study (within-subject analysis), which allows for subjects to be their own control.

Each period of the crossover consists of a 7-day out-patient treatment period followed by a single out-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Stress-Smoking Lapse Test. Upon completion, subjects will undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.

Study Timeline

• Study First Submitted: 2016-06-08
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Study Start: 2016-06-30
• Primary Completion: 2018-01-02
• Study Completion: 2018-01-02
• Results First Submitted: 2019-03-04
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-23
• Last Update Submitted: 2019-07-23
• Results First Posted: 2019-08-13
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CERC-501	CERC-501	Administered orally once daily, 10mg daily, 8 days
Placebo	Placebo	Administered orally daily, 8 days

Primary Outcome Measures

Name	Time	Method
Number of Cigarettes Smoked	60 min	Number of cigarettes smoked during the self administration period
Latency	50 min	Latency (in minutes and seconds) to time of first cigarette smoking during the delay period

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States