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

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT01046539
First received: January 8, 2010
Last updated: July 29, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Substance-Related Disorders
Drug: RDC-0313 + Buprenorphine
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Pharmacodynamics (PD) of study drug [ Time Frame: 24 hour period ] [ Designated as safety issue: Yes ]
  • VAS Scores [ Time Frame: 24 Hours period ] [ Designated as safety issue: Yes ]
  • Pupuillometry Assessments [ Time Frame: 24 Hour Period ] [ Designated as safety issue: Yes ]
  • Subjective Symptoms [ Time Frame: 15 min pre and post nal, 3 hrs post bup admin ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug [ Time Frame: 24 hour period ] [ Designated as safety issue: Yes ]
  • Max plasma concentration [ Time Frame: 24 Hour Period ] [ Designated as safety issue: Yes ]
  • Time to maximum plasma concentration [ Time Frame: 24 Hour Period ] [ Designated as safety issue: Yes ]
  • Area under the concentration time curve (AUC) [ Time Frame: 24 Hour Period ] [ Designated as safety issue: Yes ]
  • Additional PK parameters may be analyzed [ Time Frame: As appropriate ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RDC-0313 + Buprenorphine
Cohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results)
Drug: RDC-0313 + Buprenorphine
1 and 4 mg (1 dose for each) + 8 mg
Placebo Comparator: Placebo Drug: Placebo
0 mg

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046539

Locations
United States, California
Langley Porter Psychiatric Hospital
San Francisco, California, United States, 94143
Sponsors and Collaborators
Alkermes, Inc.
  More Information

No publications provided

Responsible Party: Reese Jones, M.D. / Principal Investigator, Langley Porter Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT01046539     History of Changes
Other Study ID Numbers: ALK33-008
Study First Received: January 8, 2010
Last Updated: July 29, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 22, 2014