Cigarette SmokingPhase 1/2NCT03874585
Text Messaging-Based Smoking Cessation Program for Homeless Youth
A Phase 1/2 study testing Group counseling and nicotine replacement and Group counseling, nicotine replacement, and text messaging support in people with Cigarette Smoking, run by RAND at 3 sites in United States.
Trial summary
Unaccompanied homeless youth smoke at much higher rates than non-homeless adolescents and young adults. Many homeless youth smokers are motivated to quit; yet, strategies specifically developed for this vulnerable population are lacking. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Group counseling and nicotine replacement and Group counseling, nicotine replacement, and text messaging support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 May 2019to 21 May 2020
- Phase
- Phase 1/2
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between ages of 18-25
- seeking services at one of the participating drop-in centers for homeless youth
- smoked at least 5 cigarettes per day on at least 20 days in the past month
- motivated to quit in next 30 days
- has a cell phone to receive text messages and willing to receive text messages
Who cannot join
- currently pregnant or breastfeeding, or planning to become pregnant or breastfeed in the next 6 months
- has a medical condition (based on self-report) which would prevent using the nicotine replacement product
- used pharmacotherapy to reduce or stop smoking in the past 30 days
- currently receiving other smoking cessation services
Trial locations and contacts
3 sites in 1 country.
United States3 sites
My Friend's Place
Los Angeles, California, 90028
Los Angeles LGBT Center Youth Center
Los Angeles, California, 90038
Safe Place for Youth
Venice, California, 90291
About this study
Unaccompanied homeless youth smoke at much higher rates than non-homeless adolescents and young adults. Many homeless youth smokers are motivated to quit; yet, strategies specifically developed for this vulnerable population are lacking. This study will develop and pilot test a text messaging intervention (also known as a TMI) to help homeless youth quit smoking. Text messaging can provide ongoing support for homeless youth during a quit attempt, which is important given that these youth tend to be highly mobile and lack regular access to health services. Participants in this study will be homeless youth who currently smoke and are motivated to quit smoking. All participants will receive a 30-minute group-based smoking cessation counseling session and a nicotine replacement product. Half of these smokers will also receive the TMI, for 6 weeks following the group counseling session, which will provide ongoing support for quitting. The main goal of this study is to investigate whether receiving the TMI results in greater reductions in cigarette smoking over a 3-month period compared to receiving the group counseling session alone.
- Conditions
- Cigarette Smoking
- Being tested
- Group counseling and nicotine replacement, Group counseling, nicotine replacement, and text messaging support
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group counseling and nicotine replacementBehavioural
Participants will receive a 30-minute group smoking cessation counseling session and a supply of nicotine replacement.
Group counseling, nicotine replacement, and text messaging supportBehavioural
Participants will receive a 30-minute group smoking cessation counseling session, a supply of nicotine replacement, and the 6-week text messaging intervention to provide ongoing support for quitting
| Study group | Role | What they receive |
|---|---|---|
| Standard Condition | Active comparator | Participants in the standard condition will receive a 30-minute group-based smoking cessation counseling session based on the 5 A's approach (Ask; Advise; Assess; Assist; Arrange) and free nicotine replacement. Receives: Behavioral: Group counseling and nicotine replacement |
| Enhanced Condition | Experimental | Participants in the standard condition will receive a 30-minute group-based smoking cessation counseling session based on the 5 A's approach (Ask; Advise; Assess; Assist; Arrange), free nicotine replacement, and the 6-week text messaging intervention. Receives: Behavioral: Group counseling, nicotine replacement, and text messaging support |
What is being measured
The primary outcome is the main question the study is designed to answer.
90 day continuous abstinence
Participants will self-report whether they have smoked any cigarettes between baseline and 3-month follow-up
Measured: 90 days
7 day abstinence
Participants will self-report whether they have smoked any cigarettes in the past 7 days. Self-reported abstinence will be biochemically verified.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start30 May 2019
- Primary completion21 May 2020
- Study completion21 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Tucker, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03874585
- Sponsor's protocol ID
- 27IP-0051
- Status last verified
- Jul 2020
- First submitted
- 12 Mar 2019
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen ER, Linnemayr S, Shadel WG, Zutshi R, DeYoreo M, Cabreros I, Tucker JS. Substance Use and Mental Health Outcomes from a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness. Nicotine Tob Res. 2022 Jan 1;24(1):130-134. doi: 10.1093/ntr/ntab160.
PubMed 34375409Tucker JS, Linnemayr S, Pedersen ER, Shadel WG, Zutshi R, DeYoreo M, Cabreros I. Pilot Randomized Clinical Trial of a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness. Nicotine Tob Res. 2021 Aug 29;23(10):1691-1698. doi: 10.1093/ntr/ntab055.
PubMed 33852730Linnemayr S, Zutshi R, Shadel W, Pedersen E, DeYoreo M, Tucker J. Text Messaging Intervention for Young Smokers Experiencing Homelessness: Lessons Learned From a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e23989. doi: 10.2196/23989.
PubMed 33792551Tucker JS, Pedersen ER, Linnemayr S, Shadel WG, DeYoreo M, Zutshi R. A text message intervention for quitting cigarette smoking among young adults experiencing homelessness: study protocol for a pilot randomized controlled trial. Addict Sci Clin Pract. 2020 Feb 19;15(1):11. doi: 10.1186/s13722-020-00187-6.
PubMed 32075695
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging-Based Smoking Cessation Program for Homeless Youth
- ClinicalTrials.gov ID
- NCT03874585
- Acronym / sponsor ID
- 27IP-0051
- Conditions
- Cigarette Smoking
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 21 May 2020 (actual)
- Study completion
- 21 May 2020 (actual)
- First posted
- 14 Mar 2019 (actual)
- 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.
Unaccompanied homeless youth smoke at much higher rates than non-homeless adolescents and young adults. Many homeless youth smokers are motivated to quit; yet, strategies specifically developed for this vulnerable population are lacking. This study will develop and pilot test a text messaging intervention (also known as a TMI) to help homeless youth quit smoking. Text messaging can provide ongoing support for homeless youth during a quit attempt, which is important given that these youth tend to be highly mobile and lack regular access to health services. Participants in this study will be homeless youth who currently smoke and are motivated to quit smoking. All participants will receive a 30-minute group-based smoking cessation counseling session and a nicotine replacement product. Half of these smokers will also receive the TMI, for 6 weeks following the group counseling session, which will provide ongoing support for quitting. The main goal of this study is to investigate whether receiving the TMI results in greater reductions in cigarette smoking over a 3-month period compared to receiving the group counseling session alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Condition | Active comparator | Behavioral: Group counseling and nicotine replacementParticipants in the standard condition will receive a 30-minute group-based smoking cessation counseling session based on the 5 A's approach (Ask; Advise; Assess; Assist; Arrange) and free nicotine replacement. |
| Enhanced Condition | Experimental | Behavioral: Group counseling, nicotine replacement, and text messaging supportParticipants in the standard condition will receive a 30-minute group-based smoking cessation counseling session based on the 5 A's approach (Ask; Advise; Assess; Assist; Arrange), free nicotine replacement, and the 6-week text messaging intervention. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- between ages of 18-25
- seeking services at one of the participating drop-in centers for homeless youth
- smoked at least 5 cigarettes per day on at least 20 days in the past month
- motivated to quit in next 30 days
- has a cell phone to receive text messages and willing to receive text messages
Key exclusion criteria (4 listed)
- currently pregnant or breastfeeding, or planning to become pregnant or breastfeed in the next 6 months
- has a medical condition (based on self-report) which would prevent using the nicotine replacement product
- used pharmacotherapy to reduce or stop smoking in the past 30 days
- currently receiving other smoking cessation services
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 |
|---|---|---|
| Group counseling and nicotine replacementParticipants will receive a 30-minute group smoking cessation counseling session and a supply of nicotine replacement. | Behavioural | Standard Condition |
| Group counseling, nicotine replacement, and text messaging supportParticipants will receive a 30-minute group smoking cessation counseling session, a supply of nicotine replacement, and the 6-week text messaging intervention to provide ongoing support for quitting | Behavioural | Enhanced Condition |
Primary outcome
90 day continuous abstinence
Time frame: 90 days
Participants will self-report whether they have smoked any cigarettes between baseline and 3-month follow-up
7 day abstinence
Time frame: 7 days
Participants will self-report whether they have smoked any cigarettes in the past 7 days. Self-reported abstinence will be biochemically verified.
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 22 Jul 2020.
- Derived from this study: PubMed 34375409Pedersen ER, Linnemayr S, Shadel WG, Zutshi R, DeYoreo M, Cabreros I, Tucker JS. Substance Use and Mental Health Outcomes from a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness. Nicotine Tob Res. 2022 Jan 1;24(1):130-134. doi: 10.1093/ntr/ntab160.
- Derived from this study: PubMed 33852730Tucker JS, Linnemayr S, Pedersen ER, Shadel WG, Zutshi R, DeYoreo M, Cabreros I. Pilot Randomized Clinical Trial of a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness. Nicotine Tob Res. 2021 Aug 29;23(10):1691-1698. doi: 10.1093/ntr/ntab055.
- Derived from this study: PubMed 33792551Linnemayr S, Zutshi R, Shadel W, Pedersen E, DeYoreo M, Tucker J. Text Messaging Intervention for Young Smokers Experiencing Homelessness: Lessons Learned From a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2021 Apr 1;9(4):e23989. doi: 10.2196/23989.
- Derived from this study: PubMed 32075695Tucker JS, Pedersen ER, Linnemayr S, Shadel WG, DeYoreo M, Zutshi R. A text message intervention for quitting cigarette smoking among young adults experiencing homelessness: study protocol for a pilot randomized controlled trial. Addict Sci Clin Pract. 2020 Feb 19;15(1):11. doi: 10.1186/s13722-020-00187-6.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Group counseling and nicotine replacement and Group counseling, nicotine replacement, and text messaging support in people with Cigarette Smoking, run by RAND at 3 sites 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 5 inclusion and 4 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
90 day continuous abstinence (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03874585, which also lists 4 linked publications.
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 22 Jul 2020.