Clinical trial NCT02538042: Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)
Official title: Strengthening Instrumental Extinction to Prevent Smoking Relapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2015-09-02
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in Fagerstrom Test of Nicotine Dependence Score
timeFrame: baseline - week 6
measure: Number of Participants Who Met Relapse Criteria
timeFrame: week 16
Secondary outcomes:
measure: Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement)
timeFrame: week 1, week 6
measure: Change in Number of Cigarettes Smoked Per Day (EXT Response)
timeFrame: week 3, week 6
measure: Change in Craving Score During MCE Task (MCE Response)
timeFrame: week 3, week 4, week 5
measure: Change in Post-quit Cue-reactivity
timeFrame: baseline ,week 6
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Francis J McClernon, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: