NCT03042650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2019

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

3.2 years

First QC Date

December 29, 2016

Last Update Submit

September 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Change in Timeline Follow-back Calendar

    6 Months

Other Outcomes (2)

  • Motivation measured by Readiness to Quit Ladder

    6 Months

  • Motivation measured by QSU-Brief Questionnaire for Smoking Urges

    6 Months

Study Arms (2)

Intensive Referral Intervention Group

EXPERIMENTAL

Intensive Referral Intervention will by done by trained probation officers

Behavioral: Intensive Referral Intervention Group

Standard Practice Facilitated Group

ACTIVE COMPARATOR

Standard Current Practice will be provided by untrained probation officers

Behavioral: Standard Practice Facilitated Group

Interventions

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.

Intensive Referral Intervention Group

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

Standard Practice Facilitated Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Smoking CessationSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorChemically-Induced DisordersMental Disorders

Study Officials

  • Kathleen M Grant, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2016

First Posted

February 3, 2017

Study Start

July 1, 2016

Primary Completion

September 27, 2019

Study Completion

September 27, 2019

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations