SmokingPhase 2NCT02641028
A Study in a Human Laboratory Model of Smoking Behavior
A Phase 2 study testing CERC-501 in people with Smoking, run by Janssen Research & Development, LLC at 3 sites in United States.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Smoking
- What is being tested?
- CERC-501
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 3 sitesUnited States
- Study dates
- 31 Dec 2015to 31 Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Kentucky
Lexington, Kentucky, 40508
Columbia University
New York, New York, 10032
Vince and Associates
Overland Park, Kansas, 66212
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking
- Being tested
- CERC-501, Placebo
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERC-501Drug
CERC-501
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CERC-501 | Experimental | Administered orally once daily, 15mg daily, 8 days. Receives: Drug: CERC-501 |
| Placebo | Placebo comparator | Administered orally daily, 8 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency
Latency (in minutes and seconds) to time of first cigarette smoked during the delay period
Measured: 50 min
Number of Cigarettes smoked
Number of cigarettes smoked during the self administration period
Measured: 60 min
Secondary outcomes (6)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to 4 days ( 2 each period)
Electronic Diary
Daily Smoking Diary for out-patient periods
Measured: up to 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study start31 Dec 2015
- Primary completion13 Sep 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald Marcus, MD, Study director, Avalo Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641028
- Sponsor's protocol ID
- Clin501-201
- Status last verified
- Apr 2025
- First submitted
- 15 Dec 2015
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Smoking Behavior
- ClinicalTrials.gov ID
- NCT02641028
- Acronym / sponsor ID
- Clin501-201
- Conditions
- Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2015 (actual)
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CERC-501 | Experimental | Drug: CERC-501Administered orally once daily, 15mg daily, 8 days. |
| Placebo | Placebo comparator | Drug: PlaceboAdministered orally daily, 8 days. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CERC-501CERC-501 | Drug | CERC-501 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Latency
Time frame: 50 min
Latency (in minutes and seconds) to time of first cigarette smoked during the delay period
Number of Cigarettes smoked
Time frame: 60 min
Number of cigarettes smoked during the self administration period
6 secondary outcomes
Tobacco Craving
Time frame: Up to 4 days ( 2 each period)
Mood Scores
Time frame: Up to 4 days ( 2 each period)
Nicotine Withdrawal
Time frame: Up to 4 days ( 2 each period)
Anxiety Scores
Time frame: Up to 4 days ( 2 each period)
Subject Feeling
Time frame: Up to 4 days ( 2 each period)
Electronic Diary
Time frame: up to 51 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Marcus, MD study director
Avalo Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CERC-501 in people with Smoking, run by Janssen Research & Development, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency (time frame: 50 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.