Intensive Referral to Reduce Smoking in Probationers

The purpose of this study is to determine if Intensive Referral Intervention increases motivation to quit cigarette smoking and quitting-related behaviors in probationers and also to determine if Intensive Referral Intervention improves short-term substance use outcomes in probationers with substance use disorder.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Substance Use Disorder
• Intervention / Treatment: Behavioral: Intensive Referral Intervention Group; Behavioral: Standard Practice Facilitated Group

Detailed Description

This is a longitudinal study of adults on probation who have a Substance Use Disorder (SUD) and smoke cigarettes. One-half of probation officers will be trained in the Intensive Referral Intervention (IRI) while one-half will deliver Standard Practice which is to encourage support group attendance. Research staff will assess fidelity to the IRI in trained probation officers. The investigators propose to enroll 150 probationers over a four month period and complete 3 and 6-month follow-up interviews to assess smoking and substance use measures.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Unversity of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CBR-MH Probationers in Douglas County, NE
• SUD
• daily cigarette smoker

Exclusion Criteria:

• Under guardianship
• unwilling to provide personal contact information
• unable to pass Mini-Cog

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Referral Intervention Group; Intensive Referral Intervention will by done by trained probation officers	Behavioral: Intensive Referral Intervention Group; The Intensive Referral Intervention Group will review a series of pamphlets regarding participation in 12-step meetings as well as smoking cessation that will be presented in a group setting to probationers in 3 sessions.
Active Comparator: Standard Practice Facilitated Group; Standard Current Practice will be provided by untrained probation officers	Behavioral: Standard Practice Facilitated Group; The Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation measured by Fagerstrom Test	Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Timeline Follow-back Calendar	Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar	6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation measured by Readiness to Quit Ladder	Increased Motivation to quit cigarette smoking in probationers as indicated by a change in Readiness to Quit Ladder	6 Months
Motivation measured by QSU-Brief Questionnaire for Smoking Urges	Increased Motivation to quit cigarette smoking in probationers as indicated by a change in QSU-Brief Questionnaire for Smoking Urges	6 Months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Principal Investigator: Kathleen M Grant, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): September 27, 2019
• Study Completion (Actual): September 27, 2019

Study Registration Dates

• First Submitted: December 29, 2016
• First Submitted That Met QC Criteria: February 1, 2017
• First Posted (Estimated): February 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 0018-16-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No