Tobacco SmokingNCT02918630

E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

A study testing Nicotine Patch and E-cigarette in people with Tobacco Smoking, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess if access to an electronic nicotine delivery device, or e-cigarette, in addition to nicotine patch (21 mg) can help reduce cigarette smoking among individuals diagnosed with schizophrenia compared to nicotine patch alone. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Tobacco Smoking
What is being tested?: Nicotine Patch and E-cigarette
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: Oct 2016to Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Be diagnosed with schizophrenia
Be in stable medical condition (DSM-V)
report smoking ≥10 tobacco cigarettes/day
present a breath CO ≥10 ppm
report wanting to reduce their cigarette smoking
be fluent in English
have a stable living situation

Who cannot join

be currently pregnant or breastfeeding
report wanting to quit smoking in the immediate future
test positive for illicit drugs except THC
have any illness, medical condition, or use of medications, which in the opinion of the study physicians would preclude safe and/or successful completion of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Texas Health Science Center at Houston
Houston, Texas, 77054

Other trials in United States

About this study

Conditions: Tobacco Smoking
Being tested: Nicotine Patch, E-cigarette
Keywords: E-cigarettes, Schizophrenia
Medical subject headings: Tobacco Smoking, Vaping, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nicotine PatchDrug
Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
E-cigaretteDrug
The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).

Study groups in NCT02918630
Study group	Role	What they receive
Nicotine Replacement Therapy - Nicotine Patch	Active comparator	Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning. Receives: Drug: Nicotine Patch
Nicotine Replacement Therapy + E-cigarette	Experimental	The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA). Receives: Drug: Nicotine Patch; Drug: E-cigarette

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Smoking as Assessed by Breath Carbon Monoxide Levels
Measured: Baseline, Week 5
Change in Smoking as Assessed by Urinary Cotinine Levels
Measured: Baseline, Week 5
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.
Measured: Baseline
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.
Measured: week 5

Secondary outcomes (1)

Feasibility as Assessed by Percent of Participants Who Completed the Study
Measured: week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Aug 2017

First posted29 Sep 2016 (estimated)
Study startOct 2016
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Tobacco SmokingStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02918630
Sponsor's protocol ID: HSC-MS-16-0667
Status last verified: Jun 2018
First submitted: 20 Sep 2016
Last updated: 5 Jul 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Tobacco Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
ClinicalTrials.gov ID: NCT02918630
Acronym / sponsor ID: HSC-MS-16-0667
Conditions: Tobacco Smoking
Keywords: E-cigarettes, Schizophrenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 7 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Oct 2016
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 29 Sep 2016 (estimated)
Results: Posted 5 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nicotine Replacement Therapy - Nicotine Patch	Active comparator	Drug: Nicotine PatchParticipants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
Nicotine Replacement Therapy + E-cigarette	Experimental	Drug: Nicotine Patch, Drug: E-cigaretteThe e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Be diagnosed with schizophrenia
Be in stable medical condition (DSM-V)
report smoking ≥10 tobacco cigarettes/day
present a breath CO ≥10 ppm
report wanting to reduce their cigarette smoking

Key exclusion criteria (4 listed)

be currently pregnant or breastfeeding
report wanting to quit smoking in the immediate future
test positive for illicit drugs except THC
have any illness, medical condition, or use of medications, which in the opinion of the study physicians would preclude safe and/or successful completion of the study

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
Nicotine PatchParticipants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.	Drug	Nicotine Replacement Therapy + E-cigarette, Nicotine Replacement Therapy - Nicotine Patch
E-cigaretteThe e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).	Drug	Nicotine Replacement Therapy + E-cigarette

Primary outcome

Change in Smoking as Assessed by Breath Carbon Monoxide Levels
Time frame: Baseline, Week 5
Change in Smoking as Assessed by Urinary Cotinine Levels
Time frame: Baseline, Week 5
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
Time frame: Baseline
Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.
Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back
Time frame: week 5
Timeline follow-back involves asking participants to retrospectively estimate their cigarette use in the week prior to the interview date. An average number of cigarettes per day was calculated for each participant, and the average of the average number of cigarettes per day for all participants is reported below.

1 secondary outcome

Feasibility as Assessed by Percent of Participants Who Completed the Study
Time frame: week 5

Results and safety

Results posted to the registry on 5 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nicotine Replacement Therapy - Nicotine Patch	4	4
Nicotine Replacement Therapy + E-cigarette	3	3

Primary outcome: Change in Smoking as Assessed by Breath Carbon Monoxide Levels

Time frame: Baseline, Week 5. Mean (Standard Deviation). Unit: parts per million (ppm)

Measure	Nicotine Replacement Therapy - Nicotine Patch n = 4	Nicotine Replacement Therapy + E-cigarette n = 3
Value	-18 (24)	-4.3 (3.1)

Primary outcome: Change in Smoking as Assessed by Urinary Cotinine Levels

Time frame: Baseline, Week 5. Mean (Standard Deviation). Unit: ng/mL

Measure	Nicotine Replacement Therapy - Nicotine Patch n = 4	Nicotine Replacement Therapy + E-cigarette n = 3
Value	0 (0)	0 (0)

Primary outcome: Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back

Time frame: Baseline. Mean (Standard Deviation). Unit: number of cigarettes per day

Measure	Nicotine Replacement Therapy - Nicotine Patch n = 4	Nicotine Replacement Therapy + E-cigarette n = 3
Value	13 (6)	23 (16)

Primary outcome: Number of Cigarettes Smoked Per Day as Assessed by Self-report Via Timeline Follow-back

Time frame: week 5. Mean (Standard Deviation). Unit: number of cigarettes per day

Measure	Nicotine Replacement Therapy - Nicotine Patch n = 4	Nicotine Replacement Therapy + E-cigarette n = 3
Value	9 (7)	12 (7)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nicotine Replacement Therapy - Nicotine Patch	0 of 4 (0%)	4 of 4 (100%)	0 of 4
Nicotine Replacement Therapy + E-cigarette	0 of 3 (0%)	3 of 3 (100%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Jin Ho Yoon, PhD principal investigator

The University of Texas Health Science Center, Houston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nicotine Patch and E-cigarette in people with Tobacco Smoking, run by The University of Texas Health Science Center, Houston 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 7 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 5 Jul 2018. 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?

Yes. Results are posted in the registry (first posted 5 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Smoking as Assessed by Breath Carbon Monoxide Levels (time frame: Baseline, Week 5). The study lists 4 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 NCT02918630.

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 5 Jul 2018.