A Study in a Human Laboratory Model of Smoking Behavior

NCT02641028 | Completed Phase 2

• 1 other identifier: Clin501-201
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Smoking

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Tobacco Craving

  Up to 4 days ( 2 each period)

• Mood Scores

  Up to 4 days ( 2 each period)

• Nicotine Withdrawal

  Up to 4 days ( 2 each period)

• Anxiety Scores

  Up to 4 days ( 2 each period)

• Subject Feeling

  Up to 4 days ( 2 each period)

Study Arms (2)

CERC-501

EXPERIMENTAL

Administered orally once daily, 15mg daily, 8 days.

Drug: CERC-501

Placebo

PLACEBO COMPARATOR

Administered orally daily, 8 days.

Drug: Placebo

Interventions

CERC-501 DRUG

CERC-501

CERC-501

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

Vince and Associates

Overland Park, Kansas, 66212, United States

Location

University of Kentucky

Lexington, Kentucky, 40508, United States

Location

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Aticaprant

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ronald Marcus, MD

  Avalo Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 29, 2015
• Study Start: December 31, 2015
• Primary Completion: September 13, 2016
• Study Completion: December 31, 2016
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)