A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
|ClinicalTrials.gov Identifier: NCT01334736|
Recruitment Status : Completed
First Posted : April 13, 2011
Last Update Posted : August 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Dependence||Behavioral: Usual care Behavioral: Lung age Behavioral: Contingency Management Behavioral: Lung age + Contingency Management||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users|
|Actual Study Start Date :||April 2011|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2012|
|Placebo Comparator: Usual care||
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.
|Active Comparator: Lung Age||
Behavioral: 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.
|Active Comparator: Contingency Management||
Behavioral: 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.
|Active Comparator: Lung age + Contingency Management||
Behavioral: 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.
- Biologically confirmed tobacco cessation [ Time Frame: 6 months ]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.
- Self efficacy and intention to quit [ Time Frame: 6 months ]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.
- Cessation attempts [ Time Frame: 6 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01334736
|United States, Maryland|
|Johns Hopkins ALIVE Clinic|
|Baltimore, Maryland, United States, 21287|