Innovative Interventions for Smoking Cessation

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Tobacco Use Disorder

Treatments: Other: VLNC Cigarette Plus Nicotine Patch; Other: VLNC Cigarette; Drug: Nicotine Patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01050569

0409M63686

1R01DA025598 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

Full description

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.

The following primary hypothesis will be tested:

Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Other hypotheses include:

1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Cigarette smokers will be randomized to:

1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
2. Nicotine patch for 6 weeks; or
3. VLNC cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.

Enrollment: 235 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• a) Smoking at least 10 cigarettes daily for the past year;
• b) In good physical health;
• c) No contraindications for medicinal nicotine; and
• d) Stable, good mental health.

Exclusion criteria

• a) Subjects must not be using other tobacco or nicotine products.
• b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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235 participants in 3 patient groups

VLNC Cigarette

Active Comparator group

Description:

Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks.

Treatment:

Other: VLNC Cigarette

Nicotine Patch

Active Comparator group

Description:

21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks.

Treatment:

Drug: Nicotine Patch

VLNC Cigarette plus Nicotine Patch

Experimental group

Description:

Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks

Treatment:

Other: VLNC Cigarette Plus Nicotine Patch