Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: Substance-Related Disorders
In brief
This is a single site, double-blind, randomized, placebo-controlled, crossover study to assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy, opioid-experienced, non-treatment-seeking subjects.
Key facts
- Study ID
- NCT01046539
- Run by
- National Institute on Drug Abuse (NIDA)
- People needed
- 12
- Starts
- 2010-01-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2017-01-11
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject must be capable of understanding and complying with the protocol and has signed the informed consent
- Must be 18-55 years of age
- Must have a body mass index of 18.0-30.0 kg/m2 at screening
- Female subjects must agree to use an acceptable method of contraception from date of consent and until two weeks after the last dose
- Subjects must be willing not to use alcohol-, tobacco, caffeine-, or xanthine-containing products while resident at inpatient facility
- Subjects must be an experienced opioid user who meets the following criteria: 1) has used opioids for non-therapeutic purposes (ie, for psychoactive effects) on at least 10 occasions in the past five years; 2) has used opioids at least 2 times in the two years prior to screening; and 3) is not physically dependent on opioids, as assessed by medical history and naloxone challenge performed at screening
You may not qualify if…
- Must not have any current or piror significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, hematologic, or metabolic disorders.
- Must not have current or past opioid, alcohol, or other durg dependence (excluding nicotine and caffeine) or showing signs of withdrawal following the naloxone (Narcan) challenge.
- Please contact site for additional information about other exclusion criteria.
Where it is running
- Langley Porter Psychiatric Hospital — San Francisco, California, United States
Full record on ClinicalTrials.gov
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