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Intensive Referral to Reduce Smoking in Probationers

Primary Purpose

Smoking Cessation, Substance Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intensive Referral Intervention Group
Standard Practice Facilitated Group
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking Cessation

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unversity of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive Referral Intervention Group

Standard Practice Facilitated Group

Arm Description

Intensive Referral Intervention will by done by trained probation officers

Standard Current Practice will be provided by untrained probation officers

Outcomes

Primary Outcome Measures

Motivation measured by Fagerstrom Test
Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence

Secondary Outcome Measures

Change in Timeline Follow-back Calendar
Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar

Full Information

First Posted
December 29, 2016
Last Updated
September 27, 2023
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT03042650
Brief Title
Intensive Referral to Reduce Smoking in Probationers
Official Title
Intensive Referral to Reduce Smoking in Probationers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation, Substance Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Referral Intervention Group
Arm Type
Experimental
Arm Description
Intensive Referral Intervention will by done by trained probation officers
Arm Title
Standard Practice Facilitated Group
Arm Type
Active Comparator
Arm Description
Standard Current Practice will be provided by untrained probation officers
Intervention Type
Behavioral
Intervention Name(s)
Intensive Referral Intervention Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Practice Facilitated Group
Intervention Description
The Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups.
Primary Outcome Measure Information:
Title
Motivation measured by Fagerstrom Test
Description
Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Change in Timeline Follow-back Calendar
Description
Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar
Time Frame
6 Months
Other Pre-specified Outcome Measures:
Title
Motivation measured by Readiness to Quit Ladder
Description
Increased Motivation to quit cigarette smoking in probationers as indicated by a change in Readiness to Quit Ladder
Time Frame
6 Months
Title
Motivation measured by QSU-Brief Questionnaire for Smoking Urges
Description
Increased Motivation to quit cigarette smoking in probationers as indicated by a change in QSU-Brief Questionnaire for Smoking Urges
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Grant, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unversity of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Intensive Referral to Reduce Smoking in Probationers

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