Buspirone for Opioid Tapering

NCT03521960 | Completed Phase 1 FDA Drug

• 1 other identifier: IRB00125620
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to collect preliminary data to support a grant application. The goal of the study is to evaluate whether the Food and Drug Administration (FDA)-approved and generically-available medication buspirone reduces symptoms of opioid withdrawal among patients undergoing a clinically-indicated and supervised taper from their opioid pain medications. This is premised on strong preclinical scientific support but has not yet be well-examined in humans.

Conditions

Dependency (Psychology); Opioid-Related Disorders; Pain, Chronic; Opiate Withdrawal Syndrome

Keywords

Buspirone

Outcome Measures

Primary Outcomes (2)

• Taper Completion

  Final day on which participant is enrolled in the clinic

  28 days

• Opioid Withdrawal Symptom Severity

  Daily ratings of the Subjective Opiate Withdrawal Scale (SOWS)Total Score. The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete.

  28 days

Study Arms (2)

Buspirone oral capsule

ACTIVE COMPARATOR

Buspirone (15 milligrams) administered orally three times per day

Drug: Buspirone oral capsule

Placebo oral capsule

PLACEBO COMPARATOR

Placebo administered orally three times per day

Drug: Placebo oral capsule

Interventions

Buspirone oral capsule DRUG

15 milligrams, three times daily

Also known as: Buspar

Buspirone oral capsule

Placebo oral capsule DRUG

0 milligrams (placebo), three times daily

Also known as: Placebo

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years old
• Be undergoing taper of prescribed opioid pain medications at the study site

You may not qualify if:

• Being pregnant or breastfeeding
• Past 7-day use of grapefruit juice or other strong Cytochrome (CYP) P450 inhibitors or inducers
• Have medical or psychiatric condition that is contraindicated with buspirone administration
• Current suicidality as assessed by clinic staff or the Columbia Suicide Severity Rating Scale

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind placebo controlled study. Patients are randomized to receive either active buspirone or placebo, each of which is over-encapsulated to support blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient completing a residential stay on the Pain Treatment Unit in which this study is being conducted will be enrolled and randomly assigned to receive either buspirone or placebo.

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 11, 2018
• Study Start: May 30, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)