Acceptability of Less Harmful Alternatives to Cigarettes

• Sponsor: Roswell Park Cancer Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00957424
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 67
• Location: 1
• Arm: 1
• Duration (Months): 29
• Patients Per Site Per Month: 2.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder	Behavioral: telephone-based intervention; Drug: nicotine replacement therapy; Other: informational intervention; Other: internet-based intervention; Other: questionnaire administration	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 67 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: International Study of the Acceptability of Less Harmful Alternatives to Cigarettes (ISALHAC) - A Pilot Study
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: Overall Single-armed study	Behavioral: telephone-based intervention; 10-15 minute web-based survey on a computer; Drug: nicotine replacement therapy; One week supply; Other: informational intervention; Other: internet-based intervention; Other: questionnaire administration; Given out week 2, 3 and 4.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs) [Baseline]

2. Number of Participants Willing to Try HRPs [Baseline]

3. Number of Participants That Completed 1-week Trial [One week]

4. Number of Participants Willing to Continue With Preferred HRP [1 week follow up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Roswell Park Cancer Institute	Buffalo	New York	United States	14263-0001

Sponsors and Collaborators

• Roswell Park Cancer Institute
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Martin Mahoney, MD, Roswell Park Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Roswell Park Cancer Institute
• ClinicalTrials.gov Identifier: NCT00957424
• Other Study ID Numbers: CDR0000648665; P30CA016056; RPCI-I-118207
• First Posted: Aug 12, 2009
• Last Update Posted: Feb 7, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by Roswell Park Cancer Institute: tobacco use disorder; bladder cancer; cervical cancer; esophageal cancer; gastric cancer; renal cell carcinoma; adult primary liver cancer; non-small cell lung cancer; small cell lung cancer; pancreatic cancer; hypopharyngeal cancer; laryngeal cancer; lip and oral cavity cancer; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; adult acute myeloid leukemia
• Additional relevant MeSH terms: Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Tobacco Use Disorder; Nicotine

Study Results

Participant Flow

Arm/Group Title	Noncombusted Nicotine Product With Informational Intervention
Arm/Group Description	Single-armed study
Period Title: Overall Study
STARTED	67
Follow-up #1	59
Follow-up #2	50
COMPLETED	44
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Single-armed study
Overall Participants	67
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.7 (9.59)
Gender (Count of Participants)
Female	35 52.2%
Male	32 47.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 7.5%
Not Hispanic or Latino	61 91%
Unknown or Not Reported	1 1.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	19 28.4%
White	42 62.7%
More than one race	5 7.5%
Unknown or Not Reported	1 1.5%
Region of Enrollment (participants) [Number]
United States	67 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With no Interest in Trial of Harm-reduction Products (HRPs)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall
Arm/Group Description	Single-armed study
Measure Participants	67
Number [participants]	7 10.4%

2. Primary Outcome

Title	Number of Participants Willing to Try HRPs
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall
Arm/Group Description	Single-armed study
Measure Participants	67
Number [participants]	60 89.6%

3. Primary Outcome

Title	Number of Participants That Completed 1-week Trial
Time Frame	One week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall
Arm/Group Description	Single-armed study
Measure Participants	67
Number [participants]	50 74.6%

4. Primary Outcome

Title	Number of Participants Willing to Continue With Preferred HRP
Time Frame	1 week follow up

Outcome Measure Data

Analysis Population Description

Those who completed one-week multiple product sampling

Arm/Group Title	Overall
Arm/Group Description	Single-armed study
Measure Participants	50
Number [participants]	49 73.1%

Adverse Events

Time Frame	Collected over 2 weeks while participants were using tobacco products
Arm/Group Title	Overall
Arm/Group Description	Single-armed study
All Cause Mortality
	Overall
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall
	Affected / at Risk (%)	# Events
Total	0/59 (0%)
Other (Not Including Serious) Adverse Events
	Overall
	Affected / at Risk (%)	# Events
Total	0/59 (0%)

Limitations/Caveats

About 1/3 of initial participants did not complete this study. The limited number of participants precludes identifying demographic predictors of willingness or patterns of substitution. Single armed study lacks comparison group.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.