N/A
N=34
Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)
Cigarette Smoking
Bottom Line
View on ClinicalTrials.gov: NCT02538042 ↗Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Nov 2018
Primary outcome: Primary: Change in Fagerstrom Test of Nicotine Dependence Score — .67; 1.33 score on a scale — p=0.39
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nicotine Patch (Drug); SPECTRUM Nicotine Research Cigarettes (0.07 mg) (Drug); MCE+ (Behavioral); MCE- (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Francis McClernon, Ph.D.
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fagerstrom Test of Nicotine Dependence Score |
.67; 1.33 | 0.39 |
| PRIMARY Number of Participants Who Met Relapse Criteria |
9; 11 | — |
| SECONDARY Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement) |
0; -1.32 | — |
| SECONDARY Change in Number of Cigarettes Smoked Per Day (EXT Response) |
3.05; -.35 | — |
| SECONDARY Change in Craving Score During MCE Task (MCE Response) |
14.58; 0.98; 11.88; 4.29; 8.25; 1.34 | — |
| SECONDARY Change in Post-quit Cue-reactivity |
23.2; 15.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT02538042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.