Early Phase 1
Completed N=55
Pilot Study on Mindfulness for Tobacco and Alcohol in University Students
Source: ClinicalTrials.gov NCT01679236 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Smoking Abstinence — 6; 1 participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Smoking Abstinence |
6; 1 | — |
| SECONDARY Alcohol Use in Study Subjects vs Controls |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age: 18 to 29 years
- Tobacco use of at least 10 cigarettes per day for at least 6 months
- Alcohol use of 5 or more binges/month (Binge = 5 or more drinks for males, 4 or more for females)
Exclusion Criteria
- Baseline (orientation meeting) CO level < 10
- Self report of pre-existing bipolar disorder, schizophrenia, other delusional disorder
- Self report of pre-existing diagnosis of personality disorder (e.g. borderline, antisocial, schizoaffective personality disorders)
- Self report of alcohol use of 4 drinks or more on 6 or more nights per week.
Data sourced from ClinicalTrials.gov (NCT01679236). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.