Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)

NCT02538042 | Completed Results

• 2 other identifiers: Pro00063247R21DA037753
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  week 16

Secondary Outcomes (4)

• Change From Baseline in Number of Usual Brand Cigarettes Smoked (EXT Engagement)

  week 1, week 6

• Change in Number of Cigarettes Smoked Per Day (EXT Response)

  week 3, week 6

• Change in Craving Score During MCE Task (MCE Response)

  week 3, week 4, week 5

• Change in Post-quit Cue-reactivity

  baseline ,week 6

Study Arms (2)

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.

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.

Drug: Nicotine Patch; Drug: SPECTRUM Nicotine Research Cigarettes (0.07 mg); Behavioral: MCE-

Interventions

Nicotine Patch DRUG

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.

Also known as: Nicoderm CQ

MCE+; MCE- (Control)

SPECTRUM Nicotine Research Cigarettes (0.07 mg) DRUG

For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.

Also known as: Very Low Nicotine Content Cigarettes

MCE+; MCE- (Control)

MCE- BEHAVIORAL

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.

MCE- (Control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Francis McClernon, Ph.D.: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Duke Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. F. Joseph McClernon
• Organization: Duke University

joseph.mcclernon@duke.edu

9196682963

Study Officials

• Francis J McClernon, Ph.D

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2015
• First Posted: September 2, 2015
• Study Start: October 8, 2015
• Primary Completion: September 8, 2017
• Study Completion: September 8, 2017
• Last Updated: November 14, 2018
• Results First Posted: November 14, 2018

Record last verified: 2018-10

Locations

US (1)