Olanzapine in OUD Patients

Status Withdrawn

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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05179772
Study type	Interventional
Source	University of Pennsylvania
Contact
Status	Withdrawn
Phase	Phase 2
Start date	July 28, 2022
Completion date	January 30, 2023

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06021431` - Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT	N/A
Completed	`NCT06266572` - Overcoming Stigma and Improving Outcomes for SUDs Through Education, Engagement, and Empowerment	Phase 1
Recruiting	`NCT05037682` - Pain and Opioid Management in Older Adults	N/A
Completed	`NCT06200740` - Remotely Observed Methadone Evaluation	N/A
Not yet recruiting	`NCT06441604` - Extended-release Buprenorphine as a Novel Low-dose Induction Strategy	Phase 2
Recruiting	`NCT06028126` - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial	N/A
Completed	`NCT02559973` - Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder	Phase 1
Completed	`NCT02440256` - Expanded HIV Care in Opioid Substitution Treatment (EHOST) Trial	N/A
Completed	`NCT02593474` - Medication-Assisted Treatment for Youth With Substance Use Disorders	Phase 1
Completed	`NCT05587998` - A Study to Assess the Effect of AZD4041 on Respiratory Drive in Recreational Opioid Users.	Phase 1
Terminated	`NCT04577144` - An Observational Study of Environmental and Socioeconomic Factors in Opioid Recovery - Long Term
Recruiting	`NCT06001437` - Following Outcomes Remotely Within Addiction Recovery Domains
Recruiting	`NCT05976646` - Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion	Phase 1/Phase 2
Completed	`NCT05546229` - Assessment of Methadone and Buprenorphine in Interstitial Fluid
Not yet recruiting	`NCT06416020` - Integrating MOUD in African American Community Settings (Better Together)	N/A
Not yet recruiting	`NCT06104280` - Medications for Opioid Use Disorder Photosensitive Retinal Ganglion Cell Function, Sleep, and Circadian Rhythms: Implications for Treatment	N/A
Recruiting	`NCT06206291` - Cannabidiol for Opioid Addiction	Phase 2
Completed	`NCT05552040` - START NOW in the Treatment of Opioid Addicted Individuals	N/A
Recruiting	`NCT05459922` - Adjunctive Bright Light Therapy for Opioid Use Disorder	N/A
Recruiting	`NCT05343169` - Community-based Education, Navigation, and Support Intervention for Military Veterans	N/A