Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)

NCT ID: NCT02551692

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-07

Brief Summary

The goal of this study is to evaluate the effects of varenicline versus nicotine replacement versus placebo on personal smoking environment cue (PSE) reactivity. The results of this study will inform whether first-line pharmacotherapies for nicotine dependence (e.g. nicotine patch, varenicline) alter reactivity to environment cues. The investigators propose to identify 120 regular cigarette smokers who will complete 10 visits (1 screening visit, 1 training visit, 1 camera turn-in 2 cue exposure sessions and 4 post-quit medication check sessions). Smokers will be randomized to one of three medication conditions: placebo (PLAC; n=40), transdermal nicotine patch (NRT; n=40) or varenicline (VAR; n=40) in a double blind, double-dummy design. Reactivity variables (craving, latency to smoke, and smoke intake) will be entered into 3 (Medication: NRT, VAR, PLAC) x 2 (Environment: smoking, nonsmoking) repeated measures ANOVAs with random-effects. The investigators hypothesize that personal smoking, as compared to nonsmoking environments, will be associated with greater reactivity (i.e. increased craving and smoke intake; decreased latency to smoke). A Medication x Environment interaction will be characterized by decreased reactivity to smoking as compared to nonsmoking environments in the VAR and NRT groups as compared to the PLAC group.

Conditions

Cigarette Smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

NRT

Group Type: PLACEBO_COMPARATOR

Nicotine Patch

Intervention Type: DRUG

Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.

Placebo Capsule

Intervention Type: DRUG

In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.

In the NRT group, participants will take a placebo capsule while wearing nicotine patches.

VAR

Group Type: PLACEBO_COMPARATOR

Varenicline

Intervention Type: DRUG

Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.

Placebo Nicotine Patch

Intervention Type: DRUG

In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.

In the VAR group, participants will wear a placebo patch while taking varenicline.

PLAC

Group Type: PLACEBO_COMPARATOR

Nicotine Patch

Intervention Type: DRUG

Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.

Placebo Nicotine Patch

Intervention Type: DRUG

In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.

In the VAR group, participants will wear a placebo patch while taking varenicline.

Placebo Capsule

Intervention Type: DRUG

In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.

In the NRT group, participants will take a placebo capsule while wearing nicotine patches.

Interventions

Nicotine Patch

Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.

Intervention Type: DRUG

Varenicline

Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.

Intervention Type: DRUG

Placebo Nicotine Patch

In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.

In the VAR group, participants will wear a placebo patch while taking varenicline.

Intervention Type: DRUG

Placebo Capsule

In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.

In the NRT group, participants will take a placebo capsule while wearing nicotine patches.

Intervention Type: DRUG

Other Intervention Names

NicoDerm CQ; Chantix

Eligibility Criteria

Inclusion Criteria

1. generally healthy [(i.e. ambulatory, not currently sick)]

2. between the ages of 18 and 60

3. smoking of at least 5 cig/day of a brand delivering ≥ 0.5 mg nicotine (FTC method) for > 1 year

4. an expired CO concentration of at least 10 ppm (to confirm inhalation) or urinary cotinine >1000 ng/mL (NicAlert = 6).

5. interest in quitting smoking within the timeframe of the experiment.

6. ability to identify 4 personal smoking and 4 personal non-smoking places.

Exclusion Criteria

1. immediate or no desire to quit smoking;

2. inability to attend all required experimental sessions;

3. use of psychoactive medications;

4. use of smokeless tobacco including e-cigarettes in the past 30 days;

5. current alcohol or drug abuse;

6. use of illegal drugs as measured by urine drug screen (excluding marijuana);

7. use of experimental (investigational) drugs;

8. current use of nicotine replacement therapy or other smoking cessation treatment;

9. Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety;

10. Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg);

11. Coronary heart disease;

12. Lifetime history of heart attack;

13. Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure, arrhythmia); Abnormal EKG results suggestive of ischemia or undiagnosed cardiovascular disease please consider adding if it seems reasonable. For example, ST-segment depression or elevation, T-wave abnormalities, and lack of R wave are obtained with a 12-lead EKG).

14. Active skin disorder (e.g., psoriasis) within the last year, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);

15. Medical condition that may contraindicate participation in the opinion of the investigator and study physician.(for example, EKG results)

16. Current psychiatric disease (with the exception of anxiety disorders, OCD and ADHD);

17. Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;

18. Current depression - The Prime-MD will be used to screen for current (within 2 weeks) depression. Potential subjects who score >9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;

19. Bulimia or anorexia;

20. Significant adverse reaction to Chantix/Varenicline in the past;

21. Currently pregnant, breast feeding or likely to become pregnant;

22. History of seizure disorder.

23. A quit attempt within the last 30 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis J McClernon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R01DA038442

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00063505

Identifier Type: -

Identifier Source: org_study_id