A Study in a Human Laboratory Model of Smoking Behavior

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

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

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Drug: Placebo; Drug: CERC-501

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 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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • Vince and Associates
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • University Of Kentucky
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

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. Heavy Smokers
5. Currently not seeking smoking cessation therapy
6. 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)
7. Able to read, write, and speak in English

8. 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.
9. Male subjects must agree to use a condom if partner is of childbearing potential

Exclusion Criteria:

Subjects meeting the following criteria are not eligible for the study:

1. 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)
2. Current neurological conditions that interfere with study conduct, assessment or treatment in any significant fashion
3. Any lifetime history of bipolar I, II; schizophrenia or any other psychotic disorders; personality disorders, impulse control disorders as assessed by the MINI
4. 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
5. Recent active or past history of gastric disease such as peptic ulcer disease, gastritis, upper gastrointestinal bleeding, or any gastrointestinal malignancy or precancerous condition
6. 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.)
7. Clinically significant clinical laboratory test taken during screening, without permission of the Medical Monitor
8. Elevated AST or ALT ≥ 2 times the upper limit of normal (ULN)
9. Human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C positive as determined by serology testing at Screening
10. History of severe allergies or multiple adverse drug reactions
11. Known hypersensitivity to CERC-501
12. Current use of a proton pump inhibitor or histamine 2 blocker without permission of the Medical Monitor
13. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CERC-501; Administered orally once daily, 15mg daily, 8 days.	Drug: CERC-501; CERC-501
Placebo Comparator: Placebo; Administered orally daily, 8 days.	Drug: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco Craving	Tobacco craving assessed by the Tiffany Questionnaire of Smoking Urges-Brief (QSU-Brief) prior to tobacco withdrawal (Day 7 of each Period) and prior to reinstatement of tobacco (Day 8 of each period)	Up to 4 days ( 2 each period)
Mood Scores	Mood Scores (Circumplex) prior to tobacco withdrawal (Day 7 of each Period) and prior to reinstatement of tobacco (Day 8 of each period)	Up to 4 days ( 2 each period)
Nicotine Withdrawal	Nicotine withdrawal scores will be assessed by the Minnesota Nicotine Withdrawal Scale (MNWS) prior to tobacco withdrawal (Day 7 of each Period) and prior to reinstatement of tobacco (Day 8 of each period)	Up to 4 days ( 2 each period)
Anxiety Scores	Anxiety Scores will be assessed by the Clinically Useful Depression Outcome Scale Modified for Anxious distress (CUDOS-A) prior to tobacco withdrawal (Day 7 of each Period) and prior to reinstatement of tobacco (Day 8 of each period)	Up to 4 days ( 2 each period)
Subject Feeling	Subject feelings of positive and negative effect of tobacco as assessed by the Modified Cigarette Evaluation Questionnaire (mCEQ) prior to tobacco withdrawal (Day 7 of each Period) and prior to reinstatement of tobacco (Day 8 of each period)	Up to 4 days ( 2 each period)
Electronic Diary	Daily Smoking Diary for out-patient periods	up to 51 days

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Ronald Marcus, MD, Avalo Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2015
• Primary Completion (Actual): September 13, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimated): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 24, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Aticaprant
• Other Study ID Numbers: Clin501-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO