Cigarette SmokingVLNCCueNCT02538042
Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)
A study testing Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (0.07 mg) and MCE+ in people with Cigarette Smoking, run by Francis McClernon, Ph.D. at 1 site in United States.
Trial summary
The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (0.07 mg) and MCE+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2015to 8 Sep 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- generally healthy (i.e. ambulatory, not currently sick)
- interest in quitting smoking
- smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
- an expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine > 1000 ng/mL to confirm daily smoking (NicAlert=6)
Who cannot join
- inability to attend all required experimental sessions
- desire to quit smoking prior to the study quit date
- a quit attempt resulting in greater than 3 days of abstinence in the past 30 days
- report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems)
- unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician)
- schizophrenia and schizoaffective disorder
Show all 19Show fewer
- psychiatric medication changes (e.g. new prescriptions, changes in dosages, or discontinuation of medications) in the past 3 months that was a result of negative changes in symptoms
- use of other tobacco products or e-cigarettes more than 9 days in the past 30 days
- current alcohol or drug abuse
- use of illegal drugs (excluding marijuana) or drugs without a valid prescription as measured by urine drug screen
- current use of nicotine replacement therapy or other smoking cessation treatment
- use of Theophylline for asthma
- presence of conditions contraindicated for nicotine replacement therapy (e.g., skin allergies)
- previous participation in a study within the past year involving use of Spectrum cigarettes
- systolic BP greater than or equal to 140 (participants failing for blood pressure will be allowed to rescreen once)
- diastolic BP greater than or equal to 90 (participants failing for blood pressure will be allowed to rescreen once)
- heart rate greater than or equal to 100 (participants failing for heart rate will be allowed to rescreen once)
- blood alcohol level >0.0 (participants failing the blood alcohol screen will be allowed to rescreen once)
- pregnant, trying to become pregnant, or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strengthening Instrumental Extinction to Prevent Smoking Relapse
The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes. Following taking these pictures, participants will then be switched to smoke VLNCs while wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period, half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of multiple context extinction (MCE+) during which they will view smoking-related environments and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of the three weeks, participants will quit smoking and continue to wear the nicotine patch while being followed during a 10-week abstinence period. Participants will also complete a follow-up phone call 6 months after their quit day.
- Conditions
- Cigarette Smoking
- Being tested
- Nicotine Patch, SPECTRUM Nicotine Research Cigarettes (0.07 mg), MCE+, MCE-
- 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
Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
SPECTRUM Nicotine Research Cigarettes (0.07 mg)Drug
Also called Very Low Nicotine Content Cigarettes
For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
MCE+Behavioural
During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes.
MCE-Behavioural
During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| MCE+ | Experimental | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. Receives: Drug: Nicotine Patch; Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg); Behavioral: MCE+ |
| MCE- (Control) | Other | Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. Receives: Drug: Nicotine Patch; Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg); Behavioral: MCE- |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fagerstrom Test of Nicotine Dependence Score
Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent).
Measured: baseline - week 6
Number of Participants Who Met Relapse Criteria
Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition.
Measured: week 16
Secondary outcomes (4)
Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement)
Compliance with smoking VLNCs. Reduction in usual brand (UB) cigarette use over the treatment period will be calculated for each group. Average usual brand cigarettes per day was calculated using the average number for the first 5 days of treatment (week 1) and the average number for the last 5 days of treatment (week 6). Values were calculated as number smoked at W1 minus the number smoked at W6.
Measured: week 1, week 6
Change in Number of Cigarettes Smoked Per Day (EXT Response)
Reduction in total cigarette use over the treatment period will be calculated for each group. Average cigarettes per day was calculated using the average number for the 5 days leading up to week 3 and the average number for the 5 days leading up to week 6. Values were calculated as number smoked at W3 minus the number smoked at W6. Positive values represent a decrease in smoking behavior.
Measured: week 3, week 6
Change in Craving Score During MCE Task (MCE Response)
Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving)
Measured: week 3, week 4, week 5
Change in Post-quit Cue-reactivity
Difference in craving responses. Craving at each time point was measured on a scale from 0 (no craving) to 100 (strong craving). Value reported represents difference in baseline - week 6.
Measured: baseline ,week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study start8 Oct 2015
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
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.
- 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
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francis McClernon, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Francis McClernon, Ph.D., Duke University
- Investigators
- Francis J McClernon, Ph.D, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538042
- Sponsor's protocol ID
- Pro00063247
- Other IDs
- R21DA037753
- Acronym
- VLNCCue
- Status last verified
- Oct 2018
- First submitted
- 20 Aug 2015
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strengthening Instrumental Extinction to Prevent Smoking Relapse
- ClinicalTrials.gov ID
- NCT02538042
- Acronym / sponsor ID
- VLNCCue / Pro00063247
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Francis McClernon, Ph.D.University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 8 Oct 2015 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 2 Sep 2015 (estimated)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The central objective of the project is to evaluate the effect of incorporating smoking related contexts into very low nicotine content (VLNC) cigarette extinction trials on clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking (N=80) will be interviewed and trained to take pictures where they smoke cigarettes. Following taking these pictures, participants will then be switched to smoke VLNCs while wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period, half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of multiple context extinction (MCE+) during which they will view smoking-related environments and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of the three weeks, participants will quit smoking and continue to wear the nicotine patch while being followed during a 10-week abstinence period. Participants will also complete a follow-up phone call 6 months after their quit day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCE+ | Experimental | Drug: Nicotine Patch, Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg), Behavioral: MCE+Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. |
| MCE- (Control) | Other | Drug: Nicotine Patch, Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg), Behavioral: MCE-Three weeks prior to the target quit date, participants will switch to smoking very low nicotine content cigarettes and wear a 21 mg/d nicotine patch. During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. Following the quit date, participants will quit smoking and wear the nicotine patch for 10 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- generally healthy (i.e. ambulatory, not currently sick)
- interest in quitting smoking
- smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year
- an expired carbon monoxide concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine > 1000 ng/mL to confirm daily smoking (NicAlert=6)
Key exclusion criteria (19 listed)
- inability to attend all required experimental sessions
- desire to quit smoking prior to the study quit date
- a quit attempt resulting in greater than 3 days of abstinence in the past 30 days
- report of significant health problems including but not restricted to (e.g. chronic hypertension, emphysema, seizure disorder, history of significant heart problems)
- unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the study physician)
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 CQBoth groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks. | Drug | MCE+, MCE- (Control) |
| SPECTRUM Nicotine Research Cigarettes (0.07 mg)Also: Very Low Nicotine Content CigarettesFor 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand. | Drug | MCE+, MCE- (Control) |
| MCE+During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes. | Behavioural | MCE+ |
| MCE-During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes. | Behavioural | MCE- (Control) |
Primary outcome
Change in Fagerstrom Test of Nicotine Dependence Score
Time frame: baseline - week 6
Effects of MCE+ (vs. MCE-) on pre-quit nicotine dependence. The score of the questionnaire ranges in value from 0 (not at all dependent) to 10 (highly dependent).
Number of Participants Who Met Relapse Criteria
Time frame: week 16
Effects of MCE+ (vs. MCE-) on smoking cessation outcomes. Relapse is defined as 7 consecutive days of smoking. Outcome reported as number of participants who met relapse definition.
4 secondary outcomes
Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement)
Time frame: week 1, week 6
Change in Number of Cigarettes Smoked Per Day (EXT Response)
Time frame: week 3, week 6
Change in Craving Score During MCE Task (MCE Response)
Time frame: week 3, week 4, week 5
Change in Post-quit Cue-reactivity
Time frame: baseline ,week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- 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, SPECTRUM Nicotine Research Cigarettes (0.07 mg) and MCE+ in people with Cigarette Smoking, run by Francis McClernon, Ph.D. 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 4 inclusion and 19 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 14 Nov 2018. 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. 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 14 Nov 2018). 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 Fagerstrom Test of Nicotine Dependence Score (time frame: baseline - week 6). 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 14 Nov 2018.