E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

NCT02918630 | Completed Results

• 1 other identifier: HSC-MS-16-0667
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Smoking

Keywords

E-cigarettes; Schizophrenia

Outcome Measures

Primary Outcomes (4)

• Change in Smoking as Assessed by Breath Carbon Monoxide Levels

  Baseline, Week 5

• Change in Smoking as Assessed by Urinary Cotinine Levels

  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.

  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.

  week 5

Secondary Outcomes (1)

• Feasibility as Assessed by Percent of Participants Who Completed the Study

  week 5

Study Arms (2)

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.

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).

Drug: Nicotine Patch; Drug: E-cigarette

Interventions

Nicotine Patch DRUG

Participants 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; Nicotine Replacement Therapy - Nicotine Patch

E-cigarette DRUG

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).

Nicotine Replacement Therapy + E-cigarette

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Tobacco Smoking; Vaping; Schizophrenia

Interventions

Tobacco Use Cessation Devices; Electronic Nicotine Delivery Systems

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Use; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Jin Ho Yoon, PhD
• Organization: The University of Texas Health Science Center at Houston

Jin.Ho.Yoon@uth.tmc.edu

(713) 486-2796

Study Officials

• Jin Ho Yoon, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: September 29, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: July 5, 2018
• Results First Posted: July 5, 2018

Record last verified: 2018-06

Locations

US (1)