Substance-Related DisordersPhase 1NCT01046539
Phase 1 Study to Evaluate RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
A Phase 1 study testing RDC-0313 + Buprenorphine in people with Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- RDC-0313 + Buprenorphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Langley Porter Psychiatric Hospital
San Francisco, California, 94143
About this study
Official title: A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
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.
- Conditions
- Substance-Related Disorders
- Being tested
- RDC-0313 + Buprenorphine, Placebo
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDC-0313 + BuprenorphineDrug
1 and 4 mg (1 dose for each) + 8 mg
PlaceboDrug
0 mg
| Study group | Role | What they receive |
|---|---|---|
| RDC-0313 + Buprenorphine | Active comparator | Cohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results) Receives: Drug: RDC-0313 + Buprenorphine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacodynamics (PD) of study drug
Measured: 24 hour period
VAS Scores
Measured: 24 Hours period
Pupuillometry Assessments
Measured: 24 Hour Period
Subjective Symptoms
Measured: 15 min pre and post nal, 3 hrs post bup admin
Secondary outcomes (5)
To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug
Measured: 24 hour period
Max plasma concentration
Measured: 24 Hour Period
Time to maximum plasma concentration
Measured: 24 Hour Period
Area under the concentration time curve (AUC)
Measured: 24 Hour Period
Additional PK parameters may be analyzed
Measured: As appropriate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionMar 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- Alkermes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046539
- Sponsor's protocol ID
- ALK33-008
- Status last verified
- Jul 2010
- First submitted
- 8 Jan 2010
- Last updated
- 11 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Pharmacodynamics of RDC-0313 Coadministered With Buprenorphine to Opioid-Experienced Healthy Adults
- ClinicalTrials.gov ID
- NCT01046539
- Acronym / sponsor ID
- ALK33-008
- Conditions
- Substance-Related Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- Alkermes, Inc.
- Study start
- Jan 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RDC-0313 + Buprenorphine | Active comparator | Drug: RDC-0313 + BuprenorphineCohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDC-0313 + Buprenorphine1 and 4 mg (1 dose for each) + 8 mg | Drug | RDC-0313 + Buprenorphine |
| Placebo0 mg | Drug | Placebo |
Primary outcome
Pharmacodynamics (PD) of study drug
Time frame: 24 hour period
VAS Scores
Time frame: 24 Hours period
Pupuillometry Assessments
Time frame: 24 Hour Period
Subjective Symptoms
Time frame: 15 min pre and post nal, 3 hrs post bup admin
5 secondary outcomes
To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug
Time frame: 24 hour period
Max plasma concentration
Time frame: 24 Hour Period
Time to maximum plasma concentration
Time frame: 24 Hour Period
Area under the concentration time curve (AUC)
Time frame: 24 Hour Period
Additional PK parameters may be analyzed
Time frame: As appropriate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RDC-0313 + Buprenorphine in people with Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacodynamics (PD) of study drug (time frame: 24 hour period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.