Smoking CessationNCT03042650
Intensive Referral to Reduce Smoking in Probationers
A study testing Intensive Referral Intervention Group and Standard Practice Facilitated Group in people with Smoking Cessation and Substance Use Disorder, run by University of Nebraska at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Smoking Cessation, Substance Use Disorder
- What is being tested?
- Intensive Referral Intervention Group and Standard Practice Facilitated Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2016to 27 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CBR-MH Probationers in Douglas County, NE
- SUD
- daily cigarette smoker
Who cannot join
- Under guardianship
- unwilling to provide personal contact information
- unable to pass Mini-Cog
Trial locations and contacts
1 site in 1 country.
United States1 site
Unversity of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation, Substance Use Disorder
- Being tested
- Intensive Referral Intervention Group, Standard Practice Facilitated Group
- Medical subject headings
- Smoking Cessation, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Referral Intervention GroupBehavioural
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 GroupBehavioural
The Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Referral Intervention Group | Experimental | Intensive Referral Intervention will by done by trained probation officers Receives: Behavioral: Intensive Referral Intervention Group |
| Standard Practice Facilitated Group | Active comparator | Standard Current Practice will be provided by untrained probation officers Receives: Behavioral: Standard Practice Facilitated Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation measured by Fagerstrom Test
Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence
Measured: 6 Months
Secondary outcomes (1)
Change in Timeline Follow-back Calendar
Improved short term substance use outcomes as indicated by change in Timeline Follow-back Calendar
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start1 Jul 2016
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen M Grant, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042650
- Sponsor's protocol ID
- 0018-16-FB
- Status last verified
- Sep 2023
- First submitted
- 29 Dec 2016
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Referral to Reduce Smoking in Probationers
- ClinicalTrials.gov ID
- NCT03042650
- Acronym / sponsor ID
- 0018-16-FB
- Conditions
- Smoking Cessation, Substance Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Referral Intervention Group | Experimental | Behavioral: Intensive Referral Intervention GroupIntensive Referral Intervention will by done by trained probation officers |
| Standard Practice Facilitated Group | Active comparator | Behavioral: Standard Practice Facilitated GroupStandard Current Practice will be provided by untrained probation officers |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CBR-MH Probationers in Douglas County, NE
- SUD
- daily cigarette smoker
Key exclusion criteria (3 listed)
- Under guardianship
- unwilling to provide personal contact information
- unable to pass Mini-Cog
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Referral Intervention GroupThe 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. | Behavioural | Intensive Referral Intervention Group |
| Standard Practice Facilitated GroupThe Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups. | Behavioural | Standard Practice Facilitated Group |
Primary outcome
Motivation measured by Fagerstrom Test
Time frame: 6 Months
Increased Motivation to quit cigarette smoking in probationers as indicated by change in Fagerstrom Test for Nicotine Dependence
1 secondary outcome
Change in Timeline Follow-back Calendar
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M Grant, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Referral Intervention Group and Standard Practice Facilitated Group in people with Smoking Cessation and Substance Use Disorder, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation measured by Fagerstrom Test (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.