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Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue) (VLNCCue)

Primary Purpose

Cigarette Smoking

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nicotine Patch

SPECTRUM Nicotine Research Cigarettes (0.07 mg)

MCE+

MCE-

About this trial

This is an interventional basic science trial for Cigarette Smoking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Duke Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MCE+

MCE- (Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

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.

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.

Change in Craving Score During MCE Task (MCE Response)

Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving)

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.

Full Information

NCT ID

NCT02538042

First Posted

August 20, 2015

Last Updated

October 15, 2018

Sponsor

Francis McClernon, Ph.D.

Collaborators

National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT02538042

Brief Title

Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)

Acronym

VLNCCue

Official Title

Strengthening Instrumental Extinction to Prevent Smoking Relapse

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

October 8, 2015 (Actual)

Primary Completion Date

September 8, 2017 (Actual)

Study Completion Date

September 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Francis McClernon, Ph.D.

Collaborators

National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cigarette Smoking

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

87 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MCE+

Arm Type

Experimental

Arm Description

Arm Title

MCE- (Control)

Arm Type

Other

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Nicotine Patch

Other Intervention Name(s)

Nicoderm CQ

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

SPECTRUM Nicotine Research Cigarettes (0.07 mg)

Other Intervention Name(s)

Very Low Nicotine Content Cigarettes

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

MCE+

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

MCE-

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Fagerstrom Test of Nicotine Dependence Score

Description

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).

Time Frame

baseline - week 6

Title

Number of Participants Who Met Relapse Criteria

Description

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.

Time Frame

week 16

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

week 1, week 6

Title

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

Description

Time Frame

week 3, week 6

Title

Change in Craving Score During MCE Task (MCE Response)

Description

Craving score across MCE sessions. Scores range from 0 (no craving) to 100 (extreme craving)

Time Frame

week 3, week 4, week 5

Title

Change in Post-quit Cue-reactivity

Description

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.

Time Frame

baseline ,week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francis J McClernon, Ph.D

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

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Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)

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