SmokingPhase 2NCT02800928
Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?
A Phase 2 study testing CERC-501 in people with Smoking, run by Yale University at 1 site in United States.
Trial summary
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Stress-precipitated Smoking Behavior. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2016to 2 Jan 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- 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
- 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
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- 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:
- 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
Who cannot join
- 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
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- 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
- 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
- Current use of any psychoactive medications including: antipsychotics, benzodiazepines, mood stabilizers, selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) or other antidepressants mood stabilizers
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
A Randomized, Double-Blind, Placebo-Controlled, Crossover Design Study of CERC-501 in a Human Laboratory Model of Stress-precipitated 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 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.
- 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, 10mg 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 smoking during the delay period
Measured: 50 min
Number of Cigarettes Smoked
Number of cigarettes smoked during the self administration period
Measured: 60 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study start30 Jun 2016
- Primary completion2 Jan 2018
- Study completion2 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Office of Research on Women's Health (ORWH), Janssen Pharmaceuticals
- Responsible party
- Principal investigator, Sherry McKee, Yale University
- Investigators
- Sherry McKee, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800928
- Sponsor's protocol ID
- 1602017291
- Other IDs
- P50DA033945
- Status last verified
- Jul 2019
- First submitted
- 8 Jun 2016
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does CERC-501 Attenuate Stress-precipitated Smoking Lapse?
- ClinicalTrials.gov ID
- NCT02800928
- Acronym / sponsor ID
- 1602017291
- Conditions
- Smoking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Office of Research on Women's Health (ORWH), Janssen Pharmaceuticals
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 2 Jan 2018 (actual)
- Study completion
- 2 Jan 2018 (actual)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Posted 13 Aug 2019
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 Stress-precipitated 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 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.
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, 10mg daily, 8 days |
| Placebo | Placebo comparator | Drug: PlaceboAdministered orally daily, 8 days |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 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
- Smokes at least 10 cigarettes per day on average for the past 6 months
- Fagerstrom score ≥3 at screening
Key exclusion criteria (17 listed)
- 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.
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 smoking during the delay period
Number of Cigarettes Smoked
Time frame: 60 min
Number of cigarettes smoked during the self administration period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sherry McKee, PhD principal investigator
Yale University
1 site 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 Yale University at 1 site 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 14 inclusion and 17 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 13 Aug 2019.