Intensive Referral to Reduce Smoking in Probationers

Sponsor

University of Nebraska (Other)

Overall Status

Unknown status

CT.gov ID

NCT03042650

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation Substance Use Disorder	Behavioral: Intensive Referral Intervention Group Behavioral: Standard Practice Facilitated Group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Intensive Referral to Reduce Smoking in Probationers

Study Start Date :

Jul 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Sep 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence [6 Months]

Secondary Outcome Measures

Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar [6 Months]

Other Outcome Measures

Increased Motivation to quit cigarette smoking in probationers as indicated by a change in Readiness to Quit Ladder [6 Months]
Increased Motivation to quit cigarette smoking in probationers as indicated by a change in QSU-Brief Questionnaire for Smoking Urges [6 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNMC	Omaha	Nebraska	United States	68198

Sponsors and Collaborators

University of Nebraska

Investigators

Principal Investigator: Kathleen Grant, UNMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kathleen Grant MD, Associate Professor of Internal Medicine, University of Nebraska

ClinicalTrials.gov Identifier:

NCT03042650

Other Study ID Numbers:

018-16-FB

First Posted:

Feb 3, 2017

Last Update Posted:

Jul 2, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Additional relevant MeSH terms:

Substance-Related Disorders

Study Results

No Results Posted as of Jul 2, 2019