Buspirone for Opioid Tapering
Primary Purpose
Opioid-Related Disorders, Dependency (Psychology), Pain, Chronic
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Buspirone oral capsule
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Buspirone
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years old
- Be undergoing taper of prescribed opioid pain medications at the study site
Exclusion Criteria:
- 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
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Buspirone oral capsule
Placebo oral capsule
Arm Description
Buspirone (15 milligrams) administered orally three times per day
Placebo administered orally three times per day
Outcomes
Primary Outcome Measures
Taper Completion
Final day on which participant is enrolled in the clinic
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03521960
Brief Title
Buspirone for Opioid Tapering
Official Title
Buspirone as an Adjunctive Medication for Opioid Tapering
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 30, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Buspirone (Buspar) has shown initial efficacy in reducing symptoms of opioid withdrawal in animal studies and in human patients undergoing a methadone taper. Buspirone may have pharmacologic activity in specific neurotransmitter systems that preclinical evidence suggests may be implicated in the manifestation of opioid withdrawal symptoms. Administration of buspirone during an opioid taper may improve outcomes relative to placebo. The goal of this study is to collect preliminary feasibility and efficacy data from a sample of patients undergoing clinically-indicated opioid tapering. Participant enrollment will occur at the beginning of their residential stay on the Pain Treatment Unit at Johns Hopkins Hospital. Participants will be randomly assigned to receive buspirone (15 milligrams, three times daily, for daily dose of 45 milligrams) or placebo. Daily assessments for withdrawal and requests for additional symptomatic medications will be evaluated as evidence of initial efficacy. Feasibility measures include willingness to participate and study retention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Dependency (Psychology), Pain, Chronic, Opiate Withdrawal Syndrome
Keywords
Buspirone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind placebo controlled study. Patients are randomized to receive either active buspirone or placebo, each of which is over-encapsulated to support blinding.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buspirone oral capsule
Arm Type
Active Comparator
Arm Description
Buspirone (15 milligrams) administered orally three times per day
Arm Title
Placebo oral capsule
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally three times per day
Intervention Type
Drug
Intervention Name(s)
Buspirone oral capsule
Other Intervention Name(s)
Buspar
Intervention Description
15 milligrams, three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
Placebo
Intervention Description
0 milligrams (placebo), three times daily
Primary Outcome Measure Information:
Title
Taper Completion
Description
Final day on which participant is enrolled in the clinic
Time Frame
28 days
Title
Opioid Withdrawal Symptom Severity
Description
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.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years old
Be undergoing taper of prescribed opioid pain medications at the study site
Exclusion Criteria:
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
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Buspirone for Opioid Tapering
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