Buspirone for Opioid Tapering
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/15/2018 |
| Start Date: | May 30, 2018 |
| End Date: | May 30, 2020 |
| Contact: | Stephanie Solazzo, MD |
| Email: | ssolazz1@jhmi.edu |
| Phone: | 410-550-3071 |
Buspirone as an Adjunctive Medication for Opioid Tapering
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.
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.
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.
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.
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
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