Clinical trial NCT01046539: Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
Official title: A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Alkermes, Inc.
First posted: 2010-01-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pharmacodynamics (PD) of study drug
timeFrame: 24 hour period
measure: VAS Scores
timeFrame: 24 Hours period
measure: Pupuillometry Assessments
timeFrame: 24 Hour Period
measure: Subjective Symptoms
timeFrame: 15 min pre and post nal, 3 hrs post bup admin
Secondary outcomes:
measure: To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug
timeFrame: 24 hour period
measure: Max plasma concentration
timeFrame: 24 Hour Period
measure: Time to maximum plasma concentration
timeFrame: 24 Hour Period
measure: Area under the concentration time curve (AUC)
timeFrame: 24 Hour Period
measure: Additional PK parameters may be analyzed
timeFrame: As appropriate
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Langley Porter Psychiatric Hospital
state: California
Study officials:
References: