Buspirone for Opioid Tapering

Johns Hopkins University

Status and phase: Completed; Phase 1

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

Treatments: Drug: Placebo oral capsule; Drug: Buspirone oral capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03521960

IRB00125620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

18 participants in 2 patient groups, including a placebo group

Buspirone oral capsule

Active Comparator group

Description:

Buspirone (15 milligrams) administered orally three times per day

Treatment:

Drug: Buspirone oral capsule

Placebo oral capsule

Placebo Comparator group

Description:

Placebo administered orally three times per day

Treatment:

Drug: Placebo oral capsule