A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

National Institute on Drug Abuse (NIDA)1 site in 1 country12 target enrollmentJanuary 2010

ConditionsSubstance-Related Disorders

InterventionsRDC-0313 + Buprenorphine Placebo

DrugsRDC-0313 + Buprenorphine Placebo

Overview

Phase: Phase 1
Intervention: RDC-0313 + Buprenorphine
Conditions: Substance-Related Disorders
Sponsor: National Institute on Drug Abuse (NIDA)
Enrollment: 12
Locations: 1
Primary Endpoint: VAS Scores
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

July 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

National Institute on Drug Abuse (NIDA)

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.

Arms & Interventions

RDC-0313 + Buprenorphine

Cohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results)

Intervention: RDC-0313 + Buprenorphine

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

VAS Scores

Time Frame: 24 Hours period

Pharmacodynamics (PD) of study drug

Time Frame: 24 hour period

Pupuillometry Assessments

Time Frame: 24 Hour Period

Subjective Symptoms

Time Frame: 15 min pre and post nal, 3 hrs post bup admin

Secondary Outcomes

To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug(24 hour period)
Max plasma concentration(24 Hour Period)
Time to maximum plasma concentration(24 Hour Period)
Area under the concentration time curve (AUC)(24 Hour Period)
Additional PK parameters may be analyzed(As appropriate)