Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?

NCT02800928 | Completed Phase 2 Results DMC

• 2 other identifiers: 1602017291P50DA033945
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Smoking

Outcome Measures

Primary Outcomes (2)

• Latency

  Latency (in minutes and seconds) to time of first cigarette smoking during the delay period

  50 min

• Number of Cigarettes Smoked

  Number of cigarettes smoked during the self administration period

  60 min

Study Arms (2)

CERC-501

EXPERIMENTAL

Administered orally once daily, 10mg 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: Yes
• 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
• Smokes at least 10 cigarettes per day on average for the past 6 months
• Fagerstrom score ≥3 at screening
• Currently not seeking smoking cessation therapy
• Urine dip test for cotinine concentration \>150 ng/mL
• 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)
• Able to read, write, and speak 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:
• 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.
• Male subjects must agree to use a condom if partner is of childbearing potential

You may not qualify if:

• 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
• 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)
• 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 SCID-IV
• 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.
• 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 Study MD (i.e., poorly controlled diabetes mellitus, congestive heart failure, etc.)
• Clinically significant clinical laboratory test taken during screening
• Elevated aspartate aminotransferase (AST) or alanine aminotransferase (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
• Positive ethanol breath test at screening or prior to dosing on Days 1 and 8 of each treatment period
• Positive urine drug test at screening or and/or prior to dosing on Days 1 and 8 of each treatment period except for cannabis
• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Office of Research on Women's Health (ORWH): collaborator
• Janssen Pharmaceuticals: collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Aticaprant

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Sherry McKee PhD
• Organization: Yale School of Medicine

sherry.mckee@yale.edu

203-737-3529

Study Officials

• Sherry McKee, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 15, 2016
• Study Start: June 30, 2016
• Primary Completion: January 2, 2018
• Study Completion: January 2, 2018
• Last Updated: August 13, 2019
• Results First Posted: August 13, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)