Tobacco DependenceNCT01334736
A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
A study testing Lung age, Contingency Management and Lung age + Contingency Management in people with Tobacco Dependence, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Lung age, Contingency Management and Lung age + Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active smoker
Who cannot join
- Enrollment in smoking cessation protocol
- Current use of nicotine replacement therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins ALIVE Clinic
Baltimore, Maryland, 21287
About this study
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.
- Conditions
- Tobacco Dependence
- Being tested
- Usual care, Lung age, Contingency Management, Lung age + Contingency Management
- Keywords
- smoking cessation, contingency management, spirometry, lung age
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
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 ageBehavioural
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 ManagementBehavioural
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 ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | Not described Receives: Behavioral: Usual care |
| Lung Age | Active comparator | Not described Receives: Behavioral: Lung age |
| Contingency Management | Active comparator | Not described Receives: Behavioral: Contingency Management |
| Lung age + Contingency Management | Active comparator | Not described Receives: Behavioral: Lung age + Contingency Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- American Thoracic Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334736
- Sponsor's protocol ID
- TD-10-002
- Status last verified
- Aug 2017
- First submitted
- 12 Apr 2011
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Drummond MB, Astemborski J, Lambert AA, Goldberg S, Stitzer ML, Merlo CA, Rand CS, Wise RA, Kirk GD. A randomized study of contingency management and spirometric lung age for motivating smoking cessation among injection drug users. BMC Public Health. 2014 Jul 28;14:761. doi: 10.1186/1471-2458-14-761.
PubMed 25074396
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
- ClinicalTrials.gov ID
- NCT01334736
- Acronym / sponsor ID
- TD-10-002
- Conditions
- Tobacco Dependence
- Keywords
- smoking cessation, contingency management, spirometry, lung age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- American Thoracic Society
- Study start
- Apr 2011 (actual)
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Behavioral: Usual care |
| Lung Age | Active comparator | Behavioral: Lung age |
| Contingency Management | Active comparator | Behavioral: Contingency Management |
| Lung age + Contingency Management | Active comparator | Behavioral: Lung age + Contingency Management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Active smoker
Key exclusion criteria (2 listed)
- Enrollment in smoking cessation protocol
- Current use of nicotine replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careAfter 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. | Behavioural | Usual care |
| Lung ageFor 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. | Behavioural | Lung Age |
| Contingency ManagementFor 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. | Behavioural | Contingency Management |
| Lung age + Contingency ManagementFor 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. | Behavioural | Lung age + Contingency Management |
Primary outcome
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.
2 secondary outcomes
Self efficacy and intention to quit
Time frame: 6 months
Cessation attempts
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 25074396Drummond MB, Astemborski J, Lambert AA, Goldberg S, Stitzer ML, Merlo CA, Rand CS, Wise RA, Kirk GD. A randomized study of contingency management and spirometric lung age for motivating smoking cessation among injection drug users. BMC Public Health. 2014 Jul 28;14:761. doi: 10.1186/1471-2458-14-761.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung age, Contingency Management and Lung age + Contingency Management in people with Tobacco Dependence, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biologically confirmed tobacco cessation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334736, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.