A Study of Novel Smoking Cessation Interventions in Current and Former Injection Drug Users
17 augusti 2017 uppdaterad av: Johns Hopkins University
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
100
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins ALIVE Clinic
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Active smoker
Exclusion Criteria:
- Enrollment in smoking cessation protocol
- Current use of nicotine replacement therapy
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Vanlig skötsel
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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.
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Aktiv komparator: Lung Age
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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.
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Aktiv komparator: Contingency Management
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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.
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Aktiv komparator: Lung age + Contingency Management
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Biologically confirmed tobacco cessation
Tidsram: 6 months
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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.
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6 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Self efficacy and intention to quit
Tidsram: 6 months
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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.
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6 months
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Cessation attempts
Tidsram: 6 months
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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.
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6 months
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Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 april 2011
Primärt slutförande (Faktisk)
1 juli 2012
Avslutad studie (Faktisk)
1 juli 2012
Studieregistreringsdatum
Först inskickad
12 april 2011
Först inskickad som uppfyllde QC-kriterierna
12 april 2011
Första postat (Uppskatta)
13 april 2011
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 augusti 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 augusti 2017
Senast verifierad
1 augusti 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TD-10-002
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