Cigarette SmokingNCT02551692
Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)
A study testing Nicotine Patch and Varenicline in people with Cigarette Smoking, run by Duke University at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity. The results of this study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Nicotine Patch and Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 7 Jan 2019
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- generally healthy [(i.e. ambulatory, not currently sick)]
- between the ages of 18 and 60
- smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
- an expired CO concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).
- interest in quitting smoking within the timeframe of the experiment.
- ability to identify 4 personal smoking and 4 personal non-smoking places.
Who cannot join
- immediate or no desire to quit smoking;
- inability to attend all required experimental sessions;
- use of psychoactive medications;
- use of smokeless tobacco including e-cigarettes in the past 30 days;
- current alcohol or drug abuse;
- use of illegal drugs as measured by urine drug screen (excluding marijuana);
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- use of experimental (investigational) drugs;
- current use of nicotine replacement therapy or other smoking cessation treatment;
- Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety;
- Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg);
- Coronary heart disease;
- Lifetime history of heart attack;
- Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure, arrhythmia); Abnormal EKG results suggestive of ischemia or undiagnosed cardiovascular disease please consider adding if it seems reasonable. For example, ST-segment depression or elevation, T-wave abnormalities, and lack of R wave are obtained with a 12-lead EKG).
- Active skin disorder (e.g., psoriasis) within the last year, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
- Medical condition that may contraindicate participation in the opinion of the investigator and study physician.(for example, EKG results)
- Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);
- Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
- Current depression - The Prime-MD will be used to screen for current (within 2 weeks) depression. Potential subjects who score >9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
- Bulimia or anorexia;
- Significant adverse reaction to Chantix/Varenicline in the past;
- Currently pregnant, breast feeding or likely to become pregnant;
- History of seizure disorder.
- A quit attempt within the last 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Smoking Environments on Craving and Smoking
The goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity. The results of this study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine patch, varenicline) alter reactivity to environment cues. The investigators propose to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1 training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC; n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind, double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking) repeated measures ANOVAs with random-effects. The investigators hypothesize that personal smoking, as compared to nonsmoking environments, will be associated with greater reactivity (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x Environment interaction will be characterized by decreased reactivity to smoking as compared to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.
- Conditions
- Cigarette Smoking
- Being tested
- Nicotine Patch, Varenicline, Placebo Nicotine Patch, Placebo Capsule
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine PatchDrug
Also called NicoDerm CQ
Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
VareniclineDrug
Also called Chantix
Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
Placebo Nicotine PatchDrug
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the VAR group, participants will wear a placebo patch while taking varenicline.
Placebo CapsuleDrug
In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
In the NRT group, participants will take a placebo capsule while wearing nicotine patches.
| Study group | Role | What they receive |
|---|---|---|
| NRT | Placebo comparator | Not described Receives: Drug: Nicotine Patch; Drug: Placebo Capsule |
| VAR | Placebo comparator | Not described Receives: Drug: Varenicline; Drug: Placebo Nicotine Patch |
| PLAC | Placebo comparator | Not described Receives: Drug: Nicotine Patch; Drug: Placebo Nicotine Patch; Drug: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Craving Score During Cue Exposure Task
Scores range from 0 (no craving) to 100 (extreme craving).
Measured: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Change in Latency to Smoke During Cue Exposure Task
The latency is the interval between smoking one cigarette and wanting, craving, or needing another.
Measured: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Change in Smoke Intake During Cue Exposure Task
Measured by number of puffs.
Measured: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJan 2016
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
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 Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Duke 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Francis J McClernon, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551692
- Sponsor's protocol ID
- Pro00063505
- Other IDs
- 1R01DA038442
- Status last verified
- Jan 2020
- First submitted
- 15 Sep 2015
- Last updated
- 18 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Smoking Environments on Craving and Smoking
- ClinicalTrials.gov ID
- NCT02551692
- Acronym / sponsor ID
- Pro00063505
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2016
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Posted 18 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity. The results of this study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine patch, varenicline) alter reactivity to environment cues. The investigators propose to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1 training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC; n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind, double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking) repeated measures ANOVAs with random-effects. The investigators hypothesize that personal smoking, as compared to nonsmoking environments, will be associated with greater reactivity (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x Environment interaction will be characterized by decreased reactivity to smoking as compared to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NRT | Placebo comparator | Drug: Nicotine Patch, Drug: Placebo Capsule |
| VAR | Placebo comparator | Drug: Varenicline, Drug: Placebo Nicotine Patch |
| PLAC | Placebo comparator | Drug: Nicotine Patch, Drug: Placebo Nicotine Patch, Drug: Placebo Capsule |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- generally healthy [(i.e. ambulatory, not currently sick)]
- between the ages of 18 and 60
- smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
- an expired CO concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).
- interest in quitting smoking within the timeframe of the experiment.
Key exclusion criteria (23 listed)
- immediate or no desire to quit smoking;
- inability to attend all required experimental sessions;
- use of psychoactive medications;
- use of smokeless tobacco including e-cigarettes in the past 30 days;
- current alcohol or drug abuse;
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 |
|---|---|---|
| Nicotine PatchAlso: NicoDerm CQParticipants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions. | Drug | NRT, PLAC |
| VareniclineAlso: ChantixVarenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions. | Drug | VAR |
| Placebo Nicotine PatchIn the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions. In the VAR group, participants will wear a placebo patch while taking varenicline. | Drug | PLAC, VAR |
| Placebo CapsuleIn the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions. In the NRT group, participants will take a placebo capsule while wearing nicotine patches. | Drug | NRT, PLAC |
Primary outcome
Change in Craving Score During Cue Exposure Task
Time frame: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Scores range from 0 (no craving) to 100 (extreme craving).
Change in Latency to Smoke During Cue Exposure Task
Time frame: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
The latency is the interval between smoking one cigarette and wanting, craving, or needing another.
Change in Smoke Intake During Cue Exposure Task
Time frame: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)
Measured by number of puffs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Francis J McClernon, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine Patch and Varenicline in people with Cigarette Smoking, run by Duke 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 6 inclusion and 23 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 18 Jan 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jan 2020). 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?
Change in Craving Score During Cue Exposure Task (time frame: Cue Exposure 1 (beginning of week 3) to Cue Exposure 2 (end of week 3)). The study lists 3 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 18 Jan 2020.