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OpenTrials
Completed

NCT Number: NCT02918630

E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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).

Primary outcomes

  1. Change in Smoking as Assessed by Breath Carbon Monoxide Levels

    Time frame: Baseline, Week 5

  2. Change in Smoking as Assessed by Urinary Cotinine Levels

    Time frame: Baseline, Week 5

  3. 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.

  4. 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.

Secondary outcomes

  1. Feasibility as Assessed by Percent of Participants Who Completed the Study

    Time frame: week 5

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 29, 2016
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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