A Study of Oral Ibogaine in Opioid Withdrawal (NCT05029401) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Oral Ibogaine in Opioid Withdrawal
United Kingdom116 participantsStarted 2021-04-01
Plain-language summary
Study DMX-IB 201 is a Phase 1/2a study of ibogaine consisting of an initial single ascending dose escalation stage to determine the maximum tolerated dose (MTD) or treat-to-target dose (TTD) in healthy volunteers, followed by a randomized, double-blind, placebo-controlled proof of concept stage to demonstrate the efficacy, safety and tolerability of the selected dose in opioid-dependent patients who seek medically supervised opioid withdrawal
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Important Inclusion Criteria for both Stages 1 and 2:
* Males and females between 18 years and 55 years of age.
* For Stage 1, healthy volunteers; recreational opioid use is allowed but not required for inclusion in the study.
* For Stage 2, opioid-dependent subjects (DSM-IV) seeking medically supervised opioid withdrawal and presenting with an OOWS score ≥ 5 on Day 1, prior to dosing.
* Self-report of at least 1 prior positive hallucinogen drug experience that included a meaningful altered state of consciousness. Hallucinogenic substances can include psilocybin, LSD, MDMA or other classic hallucinogens.
* Females that are not of child-bearing potential as defined within the protocol.
* Males who agree to use 1 of the acceptable contraceptive regiments and not to donate sperm from the first study drug administration to at least 90 days after the last drug administration or who are unable to procreate (as defined within the protocol).
* For Stage 1, negative urine tests for drugs of abuse (opiates, benzodiazepines, amphetamines, cannabinoids, cocaine, barbiturates, and phencyclidine), and CNS (central nervous system) prescription drugs (SSRIs \[selective serotonin reuptake inhibitors\], SNRIs \[serotonin-norepinephrine reuptake inhibitors\], mood stabilizers) both at screening and within approximately 7 days prior to dosing, and negative alcohol test.
* For Stage 2, negative blood and urine tests for methadone, buprenorphine, mitragynine, non-opioid drugs of abuse (benzodiaze…
What they're measuring
1
Stage 2 - Short Opiate Withdrawal Scale of Gossop (SOWS-Gossop) average score from Day 2 to Day 6