Ignite Creation Date:
2024-05-06 @ 9:17 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02941809
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2016-10-19
Brief Title:
Harnessing Placebo Effects in Methadone Treatment
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Open-labeled Dose-extending Placebos as an Adjunct to Methadone Treatment A Pilot Study
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
More than 2 million individuals in the United States have an Opioid Use Disorder OUD Methadone maintenance treatment is the gold standard of medication-assisted treatment for OUD but high-dose methadone is associated with cardiotoxicity and respiratory complications among other side effects These adverse effects make enhancing the effectiveness of lower doses of methadone an attractive therapeutic goal Long recognized for its capacity to enhance treatment outcomes for a wide range of neuropsychiatric disorders including pain the placebo effect offers an as-yet untested avenue to such an enhancement This approach is particularly compelling given that individuals with substance use disorder tend to have higher salience attribution and may thereby be more sensitive to placebo effects Our study combines two promising clinical methodologies-open-label placebo and conditioning-to investigate whether placebo effects can increase the effective potency of methadone in treatment-seeking OUD patients
Detailed Description:
A total of 120 newly-enrolled treatment-seeking OUD patients will be randomly assigned to one of two different groups either methadone plus daily open-label placebo OLP treatment group or methadoneTreatment as Usual TAU control Participants will meet with study team members five times over the course of three months of treatment with methadone baseline 2 weeks and 1 2 and 3 months post-baseline Throughout this study time period methadone dosages will be adjusted by an addiction clinician blind to patient assignment per standard clinical methods The primary outcome is methadone dose at three months Secondary outcomes include self-report of drug use 3-month urine toxicology screen results and treatment retention Exploratory outcomes include several environmental as well as personality factors associated with OUD and with propensity to demonstrate a placebo effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None