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Mobile Contingency Management for Smoking Cessation in Returning US Veterans
Plain-language guide to NCT02513069: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 291 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02513069
- Phase
- not phased
- Status
- completed
- Start
- 2015-01
- Completion (planned or actual)
- 2019-02-14
- Participants
- 291 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Smoking; Veterans
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).
The mCM intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, and smoking cessation medications.
It had two arms (groups): Mobile Contingency Management (mCM) (experimental) and Tele-Health for Smoking Ccessation (active comparator).
The registry classes the interventions as behavioral and other.
More on the Plan
Despite recent efforts to expand reach of smoking cessation treatment options beyond clinic based care, smoking cessation treatment including the use of smoking cessation aids remain greatly underutilized.
The development of a mobile health (mHealth) platform to provide CM has made the use of intensive CM approaches portable and feasible.
The approach is innovative because it builds upon advances in mHealth technology and will be the first evaluation of smart phone based mobile CM in conjunction with other evidence-based smoking cessation treatment for OEF/OIF/OND Veterans.
There is a surprising lack of research aimed at evaluating multi-component smoking cessation interventions that integrate CM with evidence-based cognitive-behavioral treatment and smoking cessation aids such as NRT.
Who Took Part
The registry lists 291 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Smoked at least 10 cigarettes on at least 15 of 30 days before screening. Served during OEF/OIF/OND era. Are willing to make a smoking cessation attempt.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco; are currently imprisoned or in psychiatric hospitalization; severely impaired hearing or speech such that telephone counseling is not possible.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.
It started in 2015-01 with completion listed for 2019-02-14.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: smoking, self-report (time frame: 6 month follow-up (6 months post-quit attempt)).
It also tracked 5 secondary outcomes, for example saliva cotinine, smoking, self-report, saliva cotinine, smoking, self-report and saliva cotinine.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 291 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.
Our Notes on the Compound
Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.