Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03799315
Recruitment Status : Completed
First Posted : January 10, 2019
Last Update Posted : September 14, 2020
Sponsor:
Collaborators:
Hennepin County Adult Detention Center
Brown University
Information provided by (Responsible Party):
Tyler Winkelman, Hennepin Healthcare Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Drug: Nicotine Replacement Therapy Behavioral: Counseling Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Tobacco-Related Health Disparities Among Incarcerated Individuals in Hennepin County
Actual Study Start Date : January 14, 2019
Actual Primary Completion Date : March 16, 2020
Actual Study Completion Date : August 29, 2020

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Bioverified 7-day point prevalence abstinence from smoking [ Time Frame: Over 3 weeks ]
    Bioverified 7-day point prevalence abstinence from smoking


Secondary Outcome Measures :
  1. Time to Lapse [ Time Frame: 1 week, 3 weeks, 12 weeks ]
    Days to first lapse (i.e., any cigarette use, even a puff)

  2. Time to Relapse [ Time Frame: 3 weeks, 12 weeks ]
    Days to first relapse

  3. Bio-verified 7-day point prevalence abstinence from smoking [ Time Frame: Over 12 weeks ]
    Bioverified 7-day point prevalence abstinence from smoking

  4. 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.

  5. 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.

  6. 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.

  7. Health care utilization [ Time Frame: 1 week, 3 weeks, 12 weeks ]
    Self-reported hospitalizations and use of the emergency department

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03799315


Locations
Layout table for location information
United States, Minnesota
Hennepin Healthcare Research Institute
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Hennepin Healthcare Research Institute
Hennepin County Adult Detention Center
Brown University
Publications:
Travis J, Western B, Redburn S, eds. The Growth of Incarceration in the United States: Exploring Causes and Consequences. Washington, D.C.: The National Academies Press; 2014. doi:10.17226/18613.
A randomised controlled study of the Health Intervention "SNAP" in Northern Territory prisons- where smoking is banned- to prevent relapse to smoking. Trial Review. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371923. Published October 10, 2017. Accessed December 29, 2017.
Fiore MC, Jaen CR, Baker TB, et al. Treating Tobacco Use and Dependence: 2008 Update. Rockville, MD: U.S. Department of Health and Human Services. Public Health Service; 2008. https://bphc.hrsa.gov/buckets/treatingtobacco.pdf. Accessed October 17, 2017.
Prisoner Research FAQs. HHS.gov. https://www.hhs.gov/ohrp/regulations-andpolicy/ guidance/faq/prisoner-research/index.html. Accessed December 18, 2017.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Tyler Winkelman, Clinician-Investigator, Hennepin Healthcare Research Institute
ClinicalTrials.gov Identifier: NCT03799315    
Other Study ID Numbers: RC-2018-0013
First Posted: January 10, 2019    Key Record Dates
Last Update Posted: September 14, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tyler Winkelman, Hennepin Healthcare Research Institute:
Incarceration
Smoking
Counseling
Nicotine Replacement
Disparities
Additional relevant MeSH terms:
Layout table for MeSH terms
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action