An interventional study of Commit® nicotine lozenges (4 mg) & self-help materials and Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials in Smokeless Tobacco Cessation, sponsored by Oregon Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-04.
Sponsored by Oregon Research Institute · Not applicable, Interventional, and Treatment
This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions:
Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.
The overarching aim of this line of research is to develop effective ST interventions that can be disseminated. In order to accomplish our aims, the investigators will enroll 1011 ST users in a multicenter, randomized controlled trial.
The primary aims and hypotheses to be tested in this study are the following:
To evaluate the effectiveness of a ST intervention combining the nicotine lozenge and assisted self-help (LASH) for increasing both prolonged and point prevalence all tobacco and ST abstinence rates at 6 months follow-up compared to an assisted self-help intervention (ASH)among ST users who are interested in achieving tobacco abstinence.
Hypothesis: The LASH intervention - adding the lozenge as nicotine replacement therapy(NRT)- will significantly increase both the prolonged and point prevalence all tobacco and ST abstinence rates compared to the ASH intervention at 6 months among ST users who are interested in achieving tobacco abstinence.
Hypothesis: The LASH intervention will significantly increase the point prevalence abstinence rates of all tobacco and ST at 6 months compared to the LSH intervention among ST users who are interested in achieving tobacco abstinence.
Secondary aims to be tested in this study:
The investigators will also examine an exploratory aim:
Oregon Research Institute is the lead sponsor of 70 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Self-help materials + Commit® nicotine lozenges (4 mg)
Drug: Commit® nicotine lozenges (4 mg) & self-help materials · Behavioral: Phone counseling & self-help materials
Self-help materials + Commit® nicotine lozenges (4 mg) + Phone counseling
Drug: Commit® nicotine lozenges (4 mg) & self-help materials · Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials · Behavioral: Phone counseling & self-help materials
Self-help materials + Phone counseling
Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials · Behavioral: Phone counseling & self-help materials
Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) \& instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.
Also known as: Active Comparator, Lonzenge + self-help only
Three phone counseling sessions to assist in cessation from use of all tobacco + lozenge nicotine replacement therapy (NRT) + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.
Also known as: lonzenge + phone + self-help
Three phone counseling sessions to assist in cessation from use of all tobacco + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.
Also known as: phone + self-help only
Prolonged All Tobacco Abstinence
The primary outcome measure will be self-reported prolonged abstinence from all tobacco use at 3- and 6-month follow-up.
Time frame: 6 months
Saliva Test for Bio-chemical Verification of Tobacco Abstinence
To verify self-report of prolonged abstinence, saliva will be collected once at 6 months. A salivary cotinine of \< 15 ng/mL will be adjudicated as prolonged tobacco abstinence.
Time frame: 6 months
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Oregon Research Institute