A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users

Tobacco Dependence Clinical Trial

Official title:

A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334736
• Other study ID #: TD-10-002
• Status: Completed
• Phase: N/A
• First received: April 12, 2011
• Last updated: August 17, 2017
• Start date: April 2011
• Est. completion date: July 2012

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cigarette smoking is very common in current and former injection drug users and is known to cause chronic lung diseases. Quitting smoking is proven to improve the health of people addicted to cigarettes. . Little information exists regarding the perceptions and characteristics of drug users regarding quitting smoking. Additionally, most programs designed to help people quit smoking are not very successful. One reason these programs may not work well is because it is difficult to motivate people to quit smoking. New methods of motivating changes in behavior include small monetary payments for healthy behavior and reporting breathing tests with the concept of "lung age," which is the age of an average healthy person with similar breathing test results. For example, a health care provider can report results as "Although you are 50 years old, you have the lungs for a 70 year old". In this proposal, the investigators plan to first explore the beliefs and characteristics of current and former injection drug users and how they are related to quitting smoking. The investigators then plan to study whether the use of two new methods of motivation increases the chances that this group will stop smoking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active smoker

Exclusion Criteria:

• Enrollment in smoking cessation protocol

• Current use of nicotine replacement therapy

Related Conditions & MeSH terms

• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• Usual care
After participants have completed the data collection portion of the SHIELD visit, the research assistant will provide the participant with an informational flyer regarding the risks of tobacco smoking and benefits of tobacco cessation. The participant will be provided the phone number for the Tobacco Quit Line in Maryland as well as a list of local tobacco cessation programs. Any questions will be answered by the research assistant. If the participant inquires about nicotine replacement therapy, they will be advised to contact their primary care provider to discuss potential therapeutic options. Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value. A handout with these results will be given to participants. At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
• Lung age
For individuals randomized to spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be verbally informed of spirometric results. It will be explained that lung function normally reduces with age and that smoking can damage lung as if they were aging more rapidly than normal using visual depictions. Their lung function estimates based on their chronological age and lung age will be provided. They will be informed that smoking cessation would slow the aging of their lungs. After questions are answered, the participant will receive a written report that includes enumeration of their lung age and chronological age. At initial and follow-up visits, the research assistant will provide the participant with the same informational flyer and Tobacco Quit Line in Maryland as the usual care intervention.
• Contingency Management
For individuals randomized to CM, after completion of data collection, it will be explained to the participant that they will receive monetary compensation for biological confirmation of tobacco cessation. At each visit, exhaled carbon monoxide levels will be checked. If the subject has a negative CO level, they will be compensated. If a participant has a CO consistent with recent tobacco use, (s)he will receive the payment for attending the visit, but no additional payment at that visit. Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value. A handout with these results will be given to participants. At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
• Lung age + Contingency Management
For individuals randomized to the combined contingency management + spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be described the process of contingency management as outlined above. Following this, the research assistant will then describe lung age to the participant as described above. At the end of this process, the participant will then receive the informational flyer, quit line and local tobacco cessation program information similar to the usual care intervention. At each follow-up visit, after obtaining CO level and questionnaire outcomes, appropriate CM payment, review of participant's baseline lung age and informational flyer will occur.

Locations

Country	Name	City	State
United States	Johns Hopkins ALIVE Clinic	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	American Thoracic Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biologically confirmed tobacco cessation	The primary outcome will be validated tobacco cessation at 6 months. Biologically confirmed tobacco cessation will be assessed by self-report of smoking status combined with CO measurement.	6 months
Secondary	Self efficacy and intention to quit	Self-efficacy and intention to quit smoking will be assessed at baseline using a modified version of the Prochaska stages of change questionnaire. Quit attempts will be enumerated at follow-up visits by asking participants how many quit attempts they made in the prior six months.	6 months
Secondary	Cessation attempts	Cessation attempts will be quantified as the number of sustained cessation attempts lasting more than 7 days, number of sustained cessation attempts lasting more than one month and number of daily cigarettes smoked.	6 months