Jail-Based Use of Smoking Cessation Treatment Study (JUST)

September 11, 2020 updated by: Tyler Winkelman, Hennepin Healthcare Research Institute

Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County

Smoking rates remain above 60% for individuals involved in the criminal justice system and contribute to elevated mortality rates in this population. Addressing smoking disparities among justice-involved individuals is a critical public health issue in Minnesota, one of a few states with rising incarceration rates. People who are incarcerated represent the intersection of multiple high-priority populations (disproportionately African-American, Native American, low-income, homeless, on Medicaid, and suffering from mental illness and substance use disorders). This study examines the impact of a smoking cessation intervention for individuals discharged from jail to the community on smoking abstinence. Participants will be randomized to either 1) guideline-based, in-person smoking cessation counseling during incarceration, telephone counseling after incarceration, and nicotine replacement, or 2) enhanced treatment as usual. This study's findings will be used to develop a larger, multi-site study that is fully powered to measure longer-term health and smoking cessation outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Outcome assessments will be conducted for both arms at 1 week, 3 weeks, and 12 weeks post discharge from jail. During these assessments, seven-day point prevalence abstinence will be bio-verified with exhaled carbon monoxide, and self-reported general health, physical health, mental health, and substance use measures will also be obtained. The analysis is fully powered (i.e., power > .8) to detect significant between group effects on the primary outcome (i.e., the longitudinal, between group effect on bio-verified seven-day point prevalence abstinence over the 3 weeks post discharge). All analyses will be conducted on the intent to treat sample and will utilize pre-specified logistic and linear regression models.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin Healthcare Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Use of ≥ 1 cigarette per day prior to incarceration
  • Expected release from the Hennepin Adult Detention Center to the community within 90 days
  • Age 18-64
  • English fluency
  • Lives within 20 minutes of Hennepin County Medical Center and has no plans to move away from area for 4 months
  • Willing to attempt quitting or reducing smoking at discharge
  • Has a telephone
  • Cleared for nicotine lozenge safety by jail health care provider and willing to use at discharge

Exclusion Criteria:

  • Active tuberculosis
  • Current mental health crisis (i.e., currently experiencing significant mania, psychosis, or suicidality)
  • Unable to ambulate independently
  • Acute medical condition that would impair participant's ability to follow-up for assessments
  • Expected discharge to a control institutional setting (e.g., locked state mental health facility or prison)
  • Active pregnancy
  • Heart attack within the last two weeks

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Jail-Based Use of Smoking Cessation Treatment (JUST)
Participants will receive guidline-based smoking cessation counseling while in jail and phone-based smoking cessation counseling sessions and nicotine lozenges after release from jail.
Drug: Nicotine Replacement Therapy
All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges.
Behavioral: Counseling
All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20.
No Intervention: Enhanced Treatment As Usual (TAU)
Participants will receive the usual, limited smoking cessation treatment while in jail, plus an additional health and wellness education session in jail. Nicotine lozenges will be offered at the end of the study to those who did not quit smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bioverified 7-day point prevalence abstinence from smoking
Time Frame: Over 3 weeks
Bioverified 7-day point prevalence abstinence from smoking
Over 3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Lapse
Time Frame: 1 week, 3 weeks, 12 weeks
Days to first lapse (i.e., any cigarette use, even a puff)
1 week, 3 weeks, 12 weeks
Time to Relapse
Time Frame: 3 weeks, 12 weeks
Days to first relapse
3 weeks, 12 weeks
Bio-verified 7-day point prevalence abstinence from smoking
Time Frame: Over 12 weeks
Bioverified 7-day point prevalence abstinence from smoking
Over 12 weeks
Health-related quality of life
Time Frame: 1 week, 3 weeks, 12 weeks
Self-Reported health using the SF-12 total score and physical and mental health composite scores. Lower scores indicate worse health.
1 week, 3 weeks, 12 weeks
Depressive symptoms
Time Frame: 1 week, 3 weeks, 12 weeks
The 10 item Center for Epidemiologic Studies Depression Scale (CESD-10) ranges from 0-30 with higher scores indicating higher depression symptoms.
1 week, 3 weeks, 12 weeks
Self-Reported Affect
Time Frame: 1 week, 3 weeks, 12 weeks
10-item Positive and Negative Affect Scales (PANAS). The 5-item positive affect scale on the PANAS ranges from 5-25 with higher scores indicating greater positive affect. The 5-item negative affect scale on the PANAS ranges from 5-25 with higher scores indicating greater negative affect.
1 week, 3 weeks, 12 weeks
Health care utilization
Time Frame: 1 week, 3 weeks, 12 weeks
Self-reported hospitalizations and use of the emergency department
1 week, 3 weeks, 12 weeks
Substance abuse
Time Frame: 1 week, 3 weeks, 12 weeks
Self-reported substance abuse using the Drug Abuse Screening Test-10. Higher scores indicate more severe drug abuse.
1 week, 3 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hennepin Healthcare Research Institute

Collaborators

Brown University
Hennepin County Adult Detention Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2019

Primary Completion (Actual)

March 16, 2020

Study Completion (Actual)

August 29, 2020

Study Registration Dates

First Submitted

January 4, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (Actual)

January 10, 2019

Study Record Updates

Last Update Posted (Actual)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 11, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC-2018-0013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tobacco Use

Clinical Trials on Nicotine Replacement Therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe