Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

NCT00710034 | Completed Phase 2 Results DMC

• 2 other identifiers: 1R01 CA135884-21R01CA135884
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 2

Brief Summary

For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period. For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.

Conditions

Tobacco Use Disorder

Keywords

Oral Tobacco Products; Snus; Smoking Substitution; Harm Reduction; Biomarkers of Tobacco Exposure

Outcome Measures

Primary Outcomes (3)

• Product Effect on Complete Substitution for Smoking

  Number of subjects using only the assigned study product at week 6

  6 week post smoking substitution

• Number of Cigarettes Smoked

  Cigarettes per day at mid intervention

  6 weeks post cigarette substitution

• Number of Products Used

  Pieces of product per week at mid intervention

  6 weeks post smoking substitution

Secondary Outcomes (2)

• Products Effect on Withdrawal Symptoms.

  Week 1-12 post switching

• Product Effect on Biomarkers of Exposure and Toxicity

  Baseline and Week 4 post smoking substitution

Study Arms (2)

Nicotine Gum

ACTIVE COMPARATOR

Nicotine replacement therapy (4 mg nicotine gum) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute nicotine gum for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.

Drug: Nicotine Gum

Snus

EXPERIMENTAL

Oral tobacco (Camel Snus) was provided to the participants for an 12 weeks. Participants were encouraged to completely substitute snus for cigarettes and asked to use at least 6-8 pieces a day or optimally every 1-2 h and more if necessary. They were advised to reduce consumption by half during weeks 7-9 and three-quarters during weeks 10-12.

Other: Oral tobacco

Interventions

Oral tobacco OTHER

Snus

Also known as: Camel Snus

Snus

Nicotine Gum DRUG

4 mg Nicotine gum

Also known as: Nicorette

Nicotine Gum

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smoking at least 10 cigarettes daily for the past year,
• in good physical health (no unstable medical condition;
• no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

You may not qualify if:

• Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.

Sponsors & Collaborators

• University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

• Hatsukami DK, Severson H, Anderson A, Vogel RI, Jensen J, Broadbent B, Murphy SE, Carmella S, Hecht SS. Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching. Tob Control. 2016 May;25(3):267-74. doi: 10.1136/tobaccocontrol-2014-052080. Epub 2015 May 19.

  PMID: 25991608 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Harm Reduction

Interventions

Tobacco, Smokeless; Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Tobacco Products; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Chewing Gum; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Tobacco Use Cessation Devices; Therapeutics; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dorothy Hatsukami, Ph.D.
• Organization: University of Minnesota

hatsu001@umn.edu

612-626-2121

Study Officials

• Dorothy Hatsukami, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open label trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2008
• First Posted: July 3, 2008
• Study Start: April 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2014
• Last Updated: December 6, 2017
• Results First Posted: December 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)