E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

• ClinicalTrials.gov Identifier: NCT02918630
• Recruitment Status: Completed
• First Posted: September 29, 2016
• Results First Posted: July 5, 2018
• Last Update Posted: July 5, 2018
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Jin Ho Yoon, The University of Texas Health Science Center, Houston

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Smoking	Drug: Nicotine Patch; Drug: E-cigarette	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia
• Study Start Date: October 2016
• Actual Primary Completion Date: August 2017
• Actual Study Completion Date: August 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Nicotine Replacement Therapy - Nicotine Patch; 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; Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
Experimental: Nicotine Replacement Therapy + E-cigarette; 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; Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.; Drug: E-cigarette; 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Feasibility as Assessed by Percent of Participants Who Completed the Study [ Time Frame: week 5 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Texas

University of Texas Health Science Center at Houston

Houston, Texas, United States, 77054

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Jin Ho Yoon, PhD; The University of Texas Health Science Center, Houston

  Study Documents (Full-Text)

Documents provided by Jin Ho Yoon, The University of Texas Health Science Center, Houston:

Study Protocol and Statistical Analysis Plan  [PDF] May 17, 2017

More Information

• Responsible Party: Jin Ho Yoon, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT02918630
• Other Study ID Numbers: HSC-MS-16-0667
• First Posted: September 29, 2016
• Results First Posted: July 5, 2018
• Last Update Posted: July 5, 2018
• Last Verified: June 2018

Keywords provided by Jin Ho Yoon, The University of Texas Health Science Center, Houston:

E-cigarettes; Schizophrenia

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Nicotine; Ganglionic Stimulants; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action