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NCT00957424 · REGISTRY CONDITION SEARCH

Acceptability of Less Harmful Alternatives to Cigarettes

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2017-02-07

RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and nicotine replacement therapy may be useful in helping smokers stop smoking. PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to cigarettes.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)

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outcome · POSTED

Number of Participants Willing to Try HRPs

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outcome · POSTED

Number of Participants That Completed 1-week Trial

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outcome · POSTED

Number of Participants Willing to Continue With Preferred HRP

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Currently smokes ≥ 10 cigarettes per day * Not planning to quit smoking in the next 30 days and has not tried to quit in the past 30 days * Medically eligible to receive nicotine-replacement products, based on the NYS Smokers Quitline eligibility criteria PATIENT CHARACTERISTICS: * Not pregnant or nursing * Able to read and speak English * In good general health * No history of heart attack or stroke in the past 2 weeks * No history of chest pains in the past month * No report of physician-diagnosed arrhythmia/irregular heartbeat or use of pacemaker * No report of physician-diagnosed heart disease/coronary artery disease, uncontrolled hypertension, stomach ulcer, diabetes, depression, or asthma PRIOR CONCURRENT THERAPY: * No other concurrent tobacco products or nicotine medications * No concurrent Zyban, Bupropion, Wellbutrin, Chantix, or other smoking cessation medication
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Single-armed study
    intervention Names
    1. Behavioral: telephone-based intervention
    2. Drug: nicotine replacement therapy
    3. Other: informational intervention
    4. Other: internet-based intervention
    5. Other: questionnaire administration
    label
    Overall
    type
    OTHER
interventions
  1. arm Group Labels
    1. Overall
    description
    10-15 minute web-based survey on a computer
    name
    telephone-based intervention
    type
    BEHAVIORAL
  2. arm Group Labels
    1. Overall
    description
    One week supply
    name
    nicotine replacement therapy
    type
    DRUG
  3. arm Group Labels
    1. Overall
    name
    informational intervention
    type
    OTHER
  4. arm Group Labels
    1. Overall
    name
    internet-based intervention
    type
    OTHER
  5. arm Group Labels
    1. Overall
    description
    Given out week 2, 3 and 4.
    name
    questionnaire administration
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
Enrollment
count
67
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)
    time Frame
    Baseline
  2. measure
    Number of Participants Willing to Try HRPs
    time Frame
    Baseline
  3. measure
    Number of Participants That Completed 1-week Trial
    time Frame
    One week
  4. measure
    Number of Participants Willing to Continue With Preferred HRP
    time Frame
    1 week follow up
Full study description
brief Summary
RATIONALE: A study that evaluates participants' beliefs about smokeless tobacco products and nicotine replacement therapy may be useful in helping smokers stop smoking. PURPOSE: This clinical trial is studying the acceptability of less harmful alternatives to cigarettes.
detailed Description
OBJECTIVES: Primary * To assess the impact of factual information (a fact sheet) about the relative harms of smokeless (SL)/nicotine replacement (NR) products on participants' beliefs about relative harmfulness. * To assess the impact of trying samples of NR and/or SL products on intentions to use such products as alternatives to cigarettes. Secondary * To explore the effects of factual information in regard to smoked tobacco on smokers' intentions to use such products as alternatives to cigarettes. * To assess potential barriers to use of both NR and SL products as substitutes for cigarettes. * To obtain estimates of possible effect sizes for powering a proposed comprehensive test of the likely outcomes of using these products in preference to cigarettes (and other smoked products). OUTLINE: Participants undergo a 10-15 minute web-based survey on a computer in the Tobacco Research Laboratory to assess basic demographic information; beliefs about the relative harmfulness of nicotine replacement (NR) and smokeless (SL) products, including use of relevant questions from the International Tobacco Control (ITC) 4 country survey; past experiences with NR and SL products and perceptions about them; and willingness to try samples of NR/SL products they have not previously used, or, if not willing, reasons for refusal. Participants also receive an information sheet while simultaneously hearing an audio recording of it. Participants complete questionnaires at 2, 3, and 4 weeks. Beginning 2 weeks after study intervention, some participants receive a day's supply of ≤ 4 smokeless tobacco or nicotine products and periodically undergo a breath CO and saliva and buccal cell sample collection. Surveys are completed and samples collected at 3 and 4 weeks.
Source references
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      payload sha256
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice