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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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RDC-0313 + Buprenorphine

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

Group Type ACTIVE_COMPARATOR

RDC-0313 + Buprenorphine

Intervention Type DRUG

1 and 4 mg (1 dose for each) + 8 mg

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

0 mg

Interventions

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RDC-0313 + Buprenorphine

1 and 4 mg (1 dose for each) + 8 mg

Intervention Type DRUG

Placebo

0 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No