Clinical trial NCT04011280: Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Official title: Novel Pharmacotherapy Approaches in Smokers With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Schizophrenia
Schizoaffective Disorder
Nicotine Dependence
Keywords: nicotine
varenicline
Acceptance and Commitment Therapy
schizophrenia
schizoaffective
bipolar
smoking cessation
cigarette
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Veterans Medical Research Foundation
name: University of California
First posted: 2019-07-08
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot trial is a Phase IV, 12-week, single center, randomized, double blind, parallel group comparison of low (0.5 mg twice daily with slower titration over one full week) versus standard dose (1.0 mg twice daily with standard titration) varenicline in individuals with DSM-V BD or SSD with a 12-week, post-treatment follow-up.
Primary purpose: TREATMENT

Brief summary: Approximately 60 chronic smokers with bipolar disorder, schizophrenia or schizoaffective disorder who are motivated to try to quit smoking will be randomized to receive smoking cessation treatment with the FDA-approved medication, varenicline, delivered either a) at its standard dose and titration schedule (half of the participants) versus b) at a lower dose and slower titration schedule (the other half), for 12 weeks. All smokers will choose a target quit date sometime between 8 to 35 days after starting the medication. All participants will receive ten 30-minute sessions of a behavioral treatment called Acceptance and Commitment Therapy (ACT). Participants will be followed for an additional 12 weeks off study medication. The major endpoint is the feasibility of combining ACT with the different dosing strategies. Investigators will also conduct a blood test that measures the breakdown of nicotine in the body to explore whether that measure influences treatment response and side effects.

Detailed description: This pilot feasibility trial is a Phase IV, 12-week, single center, randomized, double blind, parallel group comparison of low (0.5 mg twice daily with slower titration over one full week) versus standard dose (1.0 mg twice daily with standard titration) varenicline in individuals with DSM-V Bipolar Disorder (BD) or Schizophrenia Spectrum Disorders (SSD) with a 12-week, post-treatment follow-up. The 16 visits after screening (Weeks 0-24) include 11 in-person (with medications dispensed at weeks 0, 2, 4, 6, 8 and 10\] and 5 via telephone. Plasma will be obtained at baseline to measure participants' Nicotine Metabolite Ratio (NMR) and to identify slow versus normal nicotine metabolisers. A flexible quit date (between days 8-35) will be employed allowing varenicline preloading to occur prior to the Target Quit Date. Ten sessions of Acceptance \& Commitment Therapy (ACT) for smoking cessation will be delivered by trained counselors.

Eligibility criteria: Inclusion Criteria:

* 18-70 years of age
* Outpatients with a DSM-V diagnosis of Bipolar Disorder or Schizophrenia Spectrum Disorder
* Smoke at least 10 cigarettes per day and have an expired carbon monoxide (CO) breathalyzer of ≥ 10 ppm at screening and baseline visits
* Are motivated to quit smoking
* Have access to a mental health provider

Exclusion Criteria:

* Females who are pregnant, planning to become pregnant, or lactating
* Test positive for any non-prescribed medications or illicit drugs
* Have made a suicide attempt or engaged in self-mutilatory behavior in the past year
* Meet criteria for another Substance Use Disorder in the past month
* In the investigators' judgement, are either psychiatrically or medically unstable to safely participate
* Are currently using any other form of treatment for smoking cessation

Primary outcomes:
measure: Feasibility of Combining ACT With 2 Different Varenicline-assisted Quitting Strategies
timeFrame: Through completion of study, an average of 2 years
Secondary outcomes:
Other outcomes:
measure: Nicotine Metabolite Ratio (NMR) Exploratory Aim
timeFrame: Through completion of study, an average of 2 years
Locations:
city: La Jolla
country: United States
facility: Pacific Treatment & Research Center at UCSD
state: California
Study officials:
References: