Nicotine Dependence Clinical Trial
Official title:
Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
Verified date | May 2014 |
Source | University of Wisconsin, Madison |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
A. The study follows a randomized controlled design with approximately 60 smokers with a history of alcohol abuse age 18-29. The study will compare a 7-week mindfulness intervention to a matched 7-week education intervention to evaluate intervention effect on smoking cessation and reduction in alcohol use. The primary hypothesis is that the mindfulness intervention will yield statistically significantly higher smoking abstinence than controls as measured by carbon monoxide breath test and Time Line Follow Back at at the end of treatment (2-weeks post smoking cessation attempt).
Status | Completed |
Enrollment | 55 |
Est. completion date | September 2009 |
Est. primary completion date | September 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 29 Years |
Eligibility |
Inclusion Criteria: 1. Age: 18 to 29 years 2. Tobacco use of at least 10 cigarettes per day for at least 6 months 3. Alcohol use of 5 or more binges/month (Binge = 5 or more drinks for males, 4 or more for females) Exclusion Criteria: 1. Baseline (orientation meeting) CO level < 10 2. Self report of pre-existing bipolar disorder, schizophrenia, other delusional disorder 3. Self report of pre-existing diagnosis of personality disorder (e.g. borderline, antisocial, schizoaffective personality disorders) 4. Self report of alcohol use of 4 drinks or more on 6 or more nights per week. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Smoking Abstinence | Smoking abstinence is measured by Carbon Monoxide Breath Testing in Controls vs Study Group subjects two weeks after the quit day | 2 weeks post quit day | No |
Secondary | Alcohol Use in Study Subjects vs Controls | Timeline follow back participant self-report of daily alcohol use. | 2 weeks post quit day | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05176418 -
IV Pulsed-Nicotine as a Model of Smoking: The Effects of Dose and Delivery Rate
|
Early Phase 1 | |
Completed |
NCT04084210 -
Impact of Alternative Nicotine-Delivery Products on Combustible Cigarette Use
|
Phase 2 | |
Completed |
NCT04043728 -
Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study
|
N/A | |
Withdrawn |
NCT03707600 -
State and Trait Mediated Response to TMS in Substance Use Disorder
|
N/A | |
Recruiting |
NCT03999099 -
Targeting Orexin to Treat Nicotine Dependence
|
Phase 1 | |
Completed |
NCT03847155 -
Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery
|
N/A | |
Completed |
NCT02840435 -
Study on Sit to Quit Phone Intervention
|
N/A | |
Completed |
NCT02139930 -
Project 2: Strategies for Reducing Nicotine Content in Cigarettes
|
N/A | |
Completed |
NCT01982110 -
A Mindfulness Based Application for Smoking Cessation
|
N/A | |
Completed |
NCT01926626 -
Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers
|
Phase 2 | |
Withdrawn |
NCT01569477 -
Striving to Quit-Wisconsin Tobacco Quit Line
|
N/A | |
Completed |
NCT01685996 -
Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation
|
Phase 1/Phase 2 | |
Completed |
NCT01632189 -
The Effect of Varenicline on D2/D3 Receptor Binding in Smokers
|
N/A | |
Completed |
NCT01569490 -
Striving to Quit: First Breath
|
N/A | |
Active, not recruiting |
NCT01182766 -
New Treatment for Alcohol and Nicotine Dependence
|
Phase 2/Phase 3 | |
Completed |
NCT00996034 -
Nicotine Vaccination and Nicotinic Receptor Occupancy
|
Phase 2 | |
Completed |
NCT01061528 -
Coping Skills Treatment for Smoking Cessation
|
N/A | |
Suspended |
NCT01636336 -
Effects of Progesterone on Smoked Nicotine Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effects
|
N/A | |
Withdrawn |
NCT01589081 -
Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect
|
N/A | |
Completed |
NCT01943994 -
Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study
|
N/A |