Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?

July 23, 2019 updated by: Sherry McKee, Yale University
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Stress-precipitated Smoking Behavior.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Provides written informed consent and agrees to complete required clinic visits
  2. Male or female 21 to 60 years of age inclusive
  3. Body mass index (BMI) 18.5 to 40 kg/m2 inclusive
  4. Smokes at least 10 cigarettes per day on average for the past 6 months
  5. Fagerstrom score ≥3 at screening
  6. Currently not seeking smoking cessation therapy
  7. Urine dip test for cotinine concentration >150 ng/mL
  8. In otherwise good general health without any unstable medical conditions (as determined by medical history, medication history, physical examination, 10- or 12 lead ECG, vital signs, and clinical laboratory testing)
  9. Able to read, write, and speak English
  10. Females must be either:

    1. Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
    2. Women of childbearing potential (WOCBP) must meet the criteria below:

    i. Uses an acceptable double-barrier method of contraception as determined by the Investigator -and- ii. Is not lactating, has a negative serum beta human chorionic gonadotropin pregnancy test at screening and a negative urine pregnancy test prior to dosing on Days 1 and 8 of each treatment period.

  11. Male subjects must agree to use a condom if partner is of childbearing potential

Exclusion Criteria

  1. Have used tobacco or other nicotine containing products other than cigarettes (e.g., nicotine patches, pipe, cigars, snuff, chewing tobacco or e-cigarettes) within the past 30 days
  2. Any substance use disorder other than nicotine or caffeine as assessed by the Structured Clinical Interview-IV Axis I Disorders (SCID) for Diagnostic and Statistical Manual of Mental Disorders (DSM)
  3. Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion
  4. Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the SCID-IV
  5. Current psychiatric conditions that interfere with study conduct, assessment, or treatment in any significant fashion, such as major depressive disorder (MDD), eating disorders, post-traumatic stress disorder, etc. We will screen for worsening of symptoms of depression and/or suicidality at each medication appointment and lab sessions by having participants complete the Beck Depression Inventory (BDI) and the Columbia-Suicide Severity Rating Scale (C-SSRS). If there is a worsening of symptoms of depression and/or suicidality, the participants will speak a licensed psychologist for evaluation.
  6. Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition
  7. Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Study MD (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.)
  8. Clinically significant clinical laboratory test taken during screening
  9. Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2 times the upper limit of normal (ULN)
  10. Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening
  11. Positive ethanol breath test at screening or prior to dosing on Days 1 and 8 of each treatment period
  12. Positive urine drug test at screening or and/or prior to dosing on Days 1 and 8 of each treatment period except for cannabis
  13. History of severe allergies or multiple adverse drug reactions
  14. Known hypersensitivity to CERC-501
  15. Current use of a proton pump inhibitor or histamine 2 blocker
  16. Use of any investigational medication within 2 months prior to the start of this study or scheduled to receive an investigational drug other than the study drug during the course of this study
  17. Current use of any psychoactive medications including: antipsychotics, benzodiazepines, mood stabilizers, selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) or other antidepressants mood stabilizers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CERC-501
Administered orally once daily, 10mg daily, 8 days
CERC-501
Placebo Comparator: Placebo
Administered orally daily, 8 days
Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Sherry McKee, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

January 2, 2018

Study Completion (Actual)

January 2, 2018

Study Registration Dates

First Submitted

June 8, 2016

First Submitted That Met QC Criteria

June 10, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

August 13, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 1602017291
  • P50DA033945 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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