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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05179772
Other study ID # 850369
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date July 28, 2022
Est. completion date January 30, 2023

Study information

Verified date January 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to examine whether olanzapine (2.5 to 20mg/day) impacts opioid use in patients with opioid use disorder and comorbid SMI symptoms who are taking buprenorphine-naloxone. The specified outcomes (e.g., illicit opioid use, other drug use, sleep, MAT adherence, withdrawal and craving, thought and mood disorder symptoms) on olanzapine will be examined within-subjects for change (improvement) across the trial. Approximately 48 subjects will be enrolled. After enrollment, subjects will complete safety and baseline assessments and will be assigned open-label to 9-weeks olanzapine. Olanzapine will then be tapered over a 1-week period (or maintained if clinically indicated). Urines will be collected 2x/week throughout. The study has 4 distinct phases: 1) Screening (approx. 1-2 wks); 2) Baseline and Medication Initiation Visit (1 visit; includes safety, baseline and phenotyping measures, study medication dispensed) 3) Outpatient treatment (9 wks; 2 visits/wk, includes daily olanzapine and daily buprenorphine-naloxone (through the participants usual community treatment site and on-medication phenotyping measures); 4) Follow-up visit (1 wk after last dose of study medication).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 30, 2023
Est. primary completion date January 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - meet criteria for opioid use disorder - have symptoms of SMI - on stable dose of buprenorphine-naloxone - females must either be of non-child bearing potential or on highly-effective contraception Exclusion Criteria: - abnormal ECG - cocaine, alcohol, psychoactive use disorders - metabolic syndrome or diabetes 1 and 2 - history of seizures - stable regimen of an antipsychotic

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Olanzapine
Olanzapine (2.5 mg to 20 mg)

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania
United States Virginia Commonwealth University Richmond Virginia

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in illicit opioid use To examine whether adjunctive olanzapine (on top of buprenorphine-naloxone) changes illicit opioid use, indexed by Urine Drug Screens (UDS), in participants with OUD and symptoms of SMI. weeks 3-8
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