Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Stress-precipitated Smoking Behavior.
Full 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 out-patient testing day on Day 8. Subjects will participate in a laboratory session following the McKee Stress-Smoking Lapse Test. Upon completion, subjects will undergo a 7 day washout period followed by the second period of the crossover design and a 7-day follow-up visit.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
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:
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
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
17 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal