Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 11/16/2018 |
| Start Date: | October 8, 2015 |
| End Date: | September 8, 2017 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
