Open-label Pilot Study of Injectable Naltrexone and Oral Bupropion Among Cigarette Smokers With Schizophrenia
Overview
- Phase
- Phase 1
- Intervention
- Naltrexone (Vivitrol)
- Conditions
- Smoking Cessation
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Safety as assessed by the percentage of participants that show no serious adverse events
- Status
- Terminated
- Last Updated
- 7 months ago
Overview
Brief Summary
The purpose of this study is to assess the feasibility and safety of injectable naltrexone (NTX;380 mg) in conjunction with oral bupropion (BUP; 450 mg daily)NTX-BUP administration among individuals with schizophrenia spectrum disorders that smoke cigarettes and to evaluate change on smoking-related measures and symptoms of schizophrenia.
Investigators
Jin Ho Yoon
Associate Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •fluent in English;
- •Diagnosed with schizophrenia spectrum disorder that is currently stable;
- •Report regular cigarette smoking, average cigarette per day ≥ 5 in the past 4 weeks, and present a breath CO≥10 ppm.
- •Meet subjective and objective (urinary drug screen) measures of non-opioid use.
- •If female, present a negative pregnancy test, not be currently breast feeding, and agree to use acceptable birth control methods and receive periodic pregnancy tests during the course of the study.
- •Able to give written informed consent
- •Obtain an Evaluation to Sign Consent (ESC) score above
- •Exclusion Criteria.
- •Have suicidal or homicidal ideation requiring immediate attention.
- •Previous use of bupropion or naltrexone in the past 30 days.
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment
Intervention: Naltrexone (Vivitrol)
Treatment
Intervention: Bupropion
Outcomes
Primary Outcomes
Safety as assessed by the percentage of participants that show no serious adverse events
Time Frame: end of treatment (week 3)
Feasibility as assessed by the percentage of participants that enroll in the study
Time Frame: end of treatment (week 3)
Percentage of participants that complete 3 weeks of treatment
Time Frame: end of treatment (week 3)
Secondary Outcomes
- Change in psychiatric symptoms as assessed by the score on the Brief Psychiatric Rating Scale (BPRS)(Baseline, end of treatment (week 3))
- Change in number of cigarettes smoked per day (CPD)(Baseline, end of treatment (week 3))
- Change in smoking urges as assessed by the Questionnaire on Smoking Urges (QSU)(Baseline, end of treatment (week 3))
- Reduction in number of cigarettes consumed when price is at 0 as assessed by the Cigarette Purchasing Task (CPT)(Baseline, end of treatment (week 3))