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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03042650
Other study ID # 0018-16-FB
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2016
Est. completion date September 27, 2019

Study information

Verified date September 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date September 27, 2019
Est. primary completion date September 27, 2019
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Intervention

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.
Standard Practice Facilitated Group
The Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups.

Locations

Country Name City State
United States Unversity of Nebraska Medical Center Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Other 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
Primary 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 Change in Timeline Follow-back Calendar Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar 6 Months
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