Smoking Clinical Trial
Official title:
Mobile Contingency Management for Smoking Cessation in Returning US Veterans
Verified date | February 2020 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary goal of the study is to evaluate the effectiveness of a combined tele-health and contingency management (CM) intervention that the investigators call mobile CM, or mCM, in promoting smoking abstinence in US Veterans. The mCM intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, and smoking cessation medications. The primary aim is to evaluate how effective this intervention is in promoting smoking abstinence compared to telehealth interventions for smoking cessation.
Status | Completed |
Enrollment | 291 |
Est. completion date | February 14, 2019 |
Est. primary completion date | February 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 - Enrolled in the Durham VA for ongoing care - English speaking Exclusion Criteria: - Use and unwillingness to stop use of other forms of nicotine such as cigars, pipes, or chewing tobacco - Active diagnosis of a primary psychotic disorder per medical record - Are currently imprisoned or in psychiatric hospitalization - Severely impaired hearing or speech such that telephone counseling is not possible |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Durham VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | smoking, self-report | Participants' self-report of smoking in the past seven days will be measured at 6-month follow-up study visit. | 6 month follow-up (6 months post-quit attempt) | |
Secondary | saliva cotinine | For participants reporting smoking abstinence at 6-months post treatment follow-up, the investigators will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels. | 6 month follow-up (6 months post-quit attempt) | |
Secondary | smoking, self-report | Participants' self-report of smoking in the past seven days will be measured at approximately eight weeks after the participant's initial smoking quit attempt. | Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt) | |
Secondary | saliva cotinine | For participants reporting smoking abstinence eight weeks after their smoking quit attempt, the investigators will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels. | Approx. ten weeks after enrollment (i.e., eight weeks after smoking quit attempt) | |
Secondary | smoking, self-report | Participants' self-report of smoking in the past seven days will be measured at 3-month follow-up study visit. | 3 month follow-up (3 months post-quit attempt) | |
Secondary | saliva cotinine | For participants reporting smoking abstinence at the 3-month follow-up contact, the investigators will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels. | 3 month follow-up (3 months post-quit attempt) |
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