Overview

This trial has been completed.

Condition smoking
Treatments cerc-501, placebo
Phase phase 2
Sponsor Cerecor Inc
Start date December 2015
End date September 2016
Trial size 71 participants
Trial identifier NCT02641028, Clin501-201

Summary

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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Administered orally once daily, 15mg daily, 8 days.
cerc-501
CERC-501
(Placebo Comparator)
Administered orally daily, 8 days.
placebo
Placebo

Primary Outcomes

Measure
Latency
time frame: 50 min
Number of Cigarettes smoked
time frame: 60 min

Secondary Outcomes

Measure
Tobacco Craving
time frame: Up to 4 days ( 2 each period)
Mood Scores
time frame: Up to 4 days ( 2 each period)
Nicotine Withdrawal
time frame: Up to 4 days ( 2 each period)
Anxiety Scores
time frame: Up to 4 days ( 2 each period)
Subject Feeling
time frame: Up to 4 days ( 2 each period)
Electronic Diary
time frame: up to 51 days

Eligibility Criteria

Male or female participants from 21 years up to 60 years old.

Inclusion Criteria

  • Provides written informed consent and agrees to complete required clinic visits
  • Male or female 21 to 60 years of age inclusive
  • Body mass index (BMI) 18.5 to 40 kg/m2 inclusive
  • Heavy Smokers
  • Currently not seeking smoking cessation therapy
  • In otherwise good general health without any unstable medical conditions (as determined by medical history, medication history, physical examination, 12-lead ECG, vital signs, and clinical laboratory testing)
  • Able to read, write, and speak in English
  • Females must be either:
    • Post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile -or-
    • Women of childbearing potential (WOCBP) must meet the criteria below:
    • Uses an acceptable double-barrier method of contraception as determined by the Investigator -and-
    • 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.
  • Male subjects must agree to use a condom if partner is of childbearing potential

Exclusion Criteria

  • Any substance use disorder other than nicotine or caffeine as assessed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) substance use disorder checklist in addition to the Mini-International Neuropsychiatric Interview (MINI) (to capture both DSM-V substance use disorder diagnoses)
  • Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion
  • Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the MINI
  • 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., without permission of the medical monitor
  • Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition
  • Active, comorbid disease that might limit the ability of the subject to participate in the study as determined by the Investigator (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.)
  • Clinically significant clinical laboratory test taken during screening, without permission of the Medical Monitor
  • Elevated AST or ALT ≥ 2 times the upper limit of normal (ULN)
  • Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening
  • History of severe allergies or multiple adverse drug reactions
  • Known hypersensitivity to CERC-501
  • Current use of a proton pump inhibitor or histamine 2 blocker without permission of the Medical Monitor
  • 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

Additional Information

Official title A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior
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 in-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Smoking Lapse Test and be discharged from the clinic to undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Cerecor Inc.