Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

Phase 1

Completed

• Conditions: Substance-Related Disorders
• Interventions: Drug: RDC-0313 + Buprenorphine; Drug: Placebo

• Registration Number: NCT01046539
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-12
• Primary Completion: 2010-03
• Status Verified: 2010-07
• Study Completion: 2010-07
• Last Update Submitted: 2017-01-10
• Last Update Posted: 2017-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
RDC-0313 + Buprenorphine	RDC-0313 + Buprenorphine	Cohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results)
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
VAS Scores	24 Hours period
Pharmacodynamics (PD) of study drug	24 hour period
Pupuillometry Assessments	24 Hour Period
Subjective Symptoms	15 min pre and post nal, 3 hrs post bup admin

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Langley Porter Psychiatric Hospital; 🇺🇸 San Francisco, California, United States