Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00218452
Other study ID # 1996-04
Secondary ID R21DA018106R21-1
Status Completed
Phase Phase 0
First received September 16, 2005
Last updated April 6, 2015
Start date September 2005
Est. completion date April 2008

Study information

Verified date April 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentMayo Foundation: IRB
Study type Interventional

Clinical Trial Summary

The purpose of this study is develop and test the success of a new smoking cessation intervention that includes a component to eliminate binge drinking.


Description:

The primary aim of this pilot investigation is to develop and evaluate the acceptability and feasibility of a novel tobacco dependence intervention that includes a component to eliminate binge drinking. This study will also estimate the magnitude of the effect of the novel intervention on the cigarette smoking behavior of young adult college student smokers.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date April 2008
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

(1) Aged 18-25 years. (2) Enrolled as a student at a two or four year technical or non-technical college or university. (3) Smoked > 10 or more cigarettes per day during the past 6 months. (4) Binge drank on > 2 occasions per month during the past 3 months. Binge drinking is defined as consumption of > 5 standardized alcoholic drinks in a row for males or > 4 drinks in a row for females. (5) Able to participate fully in all aspects of the intervention and keep all scheduled appointments. (6) Willing to participate in 6 months of follow-up. (7) Willing to stop smoking and use nicotine patch therapy. (8) Willing to refrain from participating in additional smoking interventions for the duration of the study. (9) Provide written informed consent. (10) General good health as determined by screening physician or registered nurse.

Exclusion Criteria:

(1) Current (past 90 days) alcohol dependence as assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Alcohol Dependence Module. (2) Current (past 12 months) non-nicotine or alcohol drug dependence as assessed by a Drug Abuse Screening Test-20 score of > 6. (3) Current elevation of depressive symptoms (past 2 weeks) that would be indicative of clinical depression as assessed by a Beck Depression Inventory-II score of > 20. (4) Current use (past 30 days) of nicotine containing medication or tobacco products other than cigarettes. (5) Current use (past 30 days) of any other smoking cessation treatment involving behavioral or pharmacological interventions. (6) Any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (past 30 days) of myocardial infarction or stroke, history of severe skin allergies, or evidence of severe chronic dermatosis.

(7) Currently pregnant or breast feeding, or likely to become pregnant during the nicotine patch phase.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Lifestyle counseling
assigned to a 6-week individual behavioral treatment involving: 1) a novel brief office intervention for cigarette smoking that includes a treatment component intended to eliminate binge drinking

Locations

Country Name City State
United States Mayo Clinic Jacksonville Jacksonville Florida
United States University of North Florida Jacksonville Florida
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Treatment attendance quantified as the percentage of sessions attended, will be summarized separately for each treatment group and compared between groups using the rank sum test. One summary will be performed for the percentage of sessions attended face-to-face and a second summary will be performed for the percentage of sessions attended either face-to-face or via telephone. week 12 and week 24 No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06021652 - Feasibility, Adoption and Efficacy of A Virtual Reality Smoking Cessation Program for Patients Undergoing Lung Cancer Screening N/A
Completed NCT02735382 - EHR-Based and Fax-Based Referral to a Tobacco Quitline: A Comparative Study N/A
Completed NCT02557919 - Families Reduce Exposure to Smoke at Home N/A
Completed NCT01570595 - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV Phase 1/Phase 2
Completed NCT00786149 - Improving Varenicline Adherence and Outcomes in Homeless Smokers Phase 3
Completed NCT00387946 - Efficacy and Safety of Dianicline Treatment as an Aid to Smoking Cessation in Cigarette Smokers (AMERIDIAN) Phase 3
Completed NCT00124683 - Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1 Phase 2
Recruiting NCT04610931 - Study of the Effectiveness of a Virtual Reality Treatment in the Management of Smoking Cessation N/A
Enrolling by invitation NCT06042361 - Enhancing Equity in Smoke-free Housing N/A
Recruiting NCT04827420 - Mi QUIT CARE (Mile Square QUIT Community-Access-Referral-Expansion) N/A
Recruiting NCT04994444 - Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts Phase 2/Phase 3
Completed NCT05560243 - Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil N/A
Completed NCT02721082 - Changing the Default for Tobacco Treatment Phase 4
Completed NCT01885221 - A Multi-Media Approach to Partner Support in Smokeless Tobacco Cessation (UCare-ChewFree) N/A
Completed NCT03445507 - Effectiveness of a Chat Bot for Smoking Cessation: a Pragmatic Trial in Primary Care. N/A
Completed NCT04540081 - Enhancing Electronic Health Systems to Decrease the Burden of Colon Cancer, Lung Cancer, Obesity, Vaccine-Preventable Illness, and LivER Cancer N/A
Completed NCT03714191 - Optimizing the Tobacco Cessation Clinical Decision Support Tool.
Completed NCT03553992 - An Extended Facebook Intervention for Young Sexual and Gender Minority Smokers N/A
Completed NCT01699828 - Exploring Occupancy of Dopamine D3 Receptor by Buspirone in Humans Using PET Phase 1/Phase 2
Completed NCT01328431 - Treating Low-Income Smokers in the Hospital Emergency Department N/A