Clinical trial NCT02641028: A Study in a Human Laboratory Model of Smoking Behavior
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 71
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Latency
timeFrame: 50 min
measure: Number of Cigarettes smoked
timeFrame: 60 min
Secondary outcomes:
measure: Tobacco Craving
timeFrame: Up to 4 days ( 2 each period)
measure: Mood Scores
timeFrame: Up to 4 days ( 2 each period)
measure: Nicotine Withdrawal
timeFrame: Up to 4 days ( 2 each period)
measure: Anxiety Scores
timeFrame: Up to 4 days ( 2 each period)
measure: Subject Feeling
timeFrame: Up to 4 days ( 2 each period)
measure: Electronic Diary
timeFrame: up to 51 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Avalo Therapeutics, Inc.
name: Ronald Marcus, MD
role: STUDY_DIRECTOR
References: