Clinical Trials Logo
  1. Home
  2. Tobacco Use Cessation
  3. NCT01123967
  4. Details
NCT01123967 Clinical Trial

Offering Proactive Tobacco Treatment

Tobacco Use Cessation Clinical Trial

Official title:
Improved Effectiveness of Smoking Cessation Programs for Minnesota Priority Populations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01123967
Other study ID # 2009NTLS064
Secondary ID 0909S722351R01CA
Status Completed
Phase N/A
First received May 12, 2010
Last updated May 26, 2015
Start date February 2011
Est. completion date August 2014

Study information
Verified date May 2015
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).

Description:

Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).

Recruitment information / eligibility
Status Completed
Enrollment 2500
Est. completion date August 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria:

- Must complete the baseline survey

- Current self-reported cigarette smoker

- Has a valid home address

- An adequate proficiency in English to complete study surveys and participate in telephone counseling.

exclusion Criteria:

- adult smokers not enrolled in the Minnesota Health Care Programs (MHCP).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• proactive outreach (PRO)
a mailed invitation letter followed by telephone outreach
• telephone counseling (TC)
free telephone counseling
• Nicotine replacement therapy (NRT)
free nicotine replacement therapy (NRT)
• Usual care (UC)
nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)

Locations
Country Name City State
United States Steven Fu, M.D. Minneapolis Minnesota

Sponsors (2)
Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Results in Abstinence Rates Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers. 1 Year No
Secondary Results in Treatment Utilization Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level tobacco treatment utilization rates among a diverse population of low income smokers. 1 Year No
Secondary Cost-Effectiveness of Program Determine the cost-effectiveness of PRO+NRT+TC compared with UC. 1 Year 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 NCT00218452 - Smoking Cessation for Young Adults Who Binge Drink - 1 Phase 0
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 NCT04994444 - Preloading With Nicotine Replacement Therapy in HIV-positive Smokers to Improve Self-Efficacy and Quit Attempts Phase 2/Phase 3
Recruiting NCT04827420 - Mi QUIT CARE (Mile Square QUIT Community-Access-Referral-Expansion) N/A
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