Evaluating Buspirone to Treat Opioid Withdrawal
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Maryland, Baltimore
About this trial
The investigators propose a rigorous, Phase II, three-group, placebo-controlled double-blind randomized controlled trial (RCT) to evaluate the efficacy of buspirone for both withdrawal and craving among individuals with opioid use disorder (OUD) undergoing a standardized stepwise taper. During this 10 to 12-day residential study, participants with OUD will be enrolled, stabilized on a short-acting opioid, undergo an opioid stepwise taper, and complete a post-taper observation period where participants will have the opportunity to initiate long-term buprenorphine or extended-release naltrexone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-75
Opioid positive urine sample
Current moderate-severe opioid use disorder with evidence of physical dependence
Interested in undergoing opioid detoxification
Disqualifiers
Being pregnant or breastfeeding
Enrolled in methadone or buprenorphine maintenance treatment
Allergic to study medication or taking medications that are contraindicated with study medication (e.g., CYP3A4 inhibitors or inducers and/or monoamine oxidase (MAO) inhibitors)
Significant mental health or physical disorder, or life circumstance, that is expected to interfere with study participation (detailed further in protection of human subjects form).
Trial design
Design model
Parallel
Treatments tested in this trial
Buspirone
DrugBuspirone administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).
Lofexidine
DrugLofexidine administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).
Placebo
DrugParticipants administration begins 2 days prior to opioid taper (study day -2) and continues until the second day of the post-taper observation phase (study day 7).
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: opioid stepwise taper + buspironeExperimental treatment 1 intervention
Group B: opioid stepwise taper + lofexidineActive comparator 1 intervention
Group C: opioid stepwise taper + placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Opioid Withdrawal as assessed by the Subjective Opiate Withdrawal Scale (SOWS)
Opioid withdrawal severity will be measured with the Subjective Opiate Withdrawal Scale (SOWS) and will be computed as a daily peak total SOWS score for study days -2 to 8. The SOWS consists of 16 opioid withdrawal symptoms that are assessed for severity on a scale from 0-4 ("Not at all" to "Extremely"). Total scores range from 0-64 where a score between 0-10 is considered mild, between 11-20 is considered moderate, and greater than 21 is considered severe.
Time frame
Days -2 to 8Secondary outcomes
1
Change in tonic craving scores
Craving will be measured by tonic craving will be computed as daily peak total craving scores. The tonic craving assessment consists of 5 items related to craving that are completed on a visual analog scale (VAS) where 0 = not at all and 100 = A lot.
Time frame
Days -2 to 82
Change in cue-induced craving scores
Cue-induced craving will be computed as total craving scores before and after the craving task. The craving assessment consists of 5 items related to craving that are completed on a visual analog scale (VAS) where 0 = not at all and 100 = A lot.
Time frame
Days -2 to 83
Change in stress-induced craving scores
Stress-induced craving will be computed as total craving scores before and after stress/craving task. The craving assessment consists of 5 items related to craving that are completed on a visual analog scale (VAS) where 0 = not at all and 100 = A lot.
Time frame
Days -2 to 84
Frequency of Adverse Events
Safety will be assessed with the number of adverse events per treatment condition not including unrelated adverse events.
Time frame
Up to day 8Sponsors and contacts
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Source ClinicalTrials.gov