Methamphetamine DependencePhase 2NCT01377662
PHASE IIA: Trial of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)(OND003IND)
A Phase 2 study testing OND-PR002 and MPh-IR in people with Methamphetamine Dependence and Cocaine Dependence, run by Tong Lee at 3 sites in United States.
Trial summary
The main purpose of this study is to determine the outcome of a drug combination treatment on detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Methamphetamine Dependence, Cocaine Dependence
- What is being tested?
- OND-PR002 and MPh-IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2011to May 2013
- Phase
- Phase 2
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must give written informed consent.
- Detoxified METH/COC-dependent male and/or female subjects between 18 and 45.
- Females with Body Mass Index (BMI) of 18-36 kg/m2. Males with BMI of 20-36 kg/m2.
- Subjects in good health determined by screening examination.
- Subject must have adequate veins for intravenous site.
- Subjects must be mentally stable for minimum of 3 months.
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- Non-clinically significant hematology clinical laboratory results.
- Subjects must have hematocrit of greater than or equal to 33%.
- Non-clinically significant screening 12-lead ECG and QT interval (time for ventricular depolarization and repolarization to occur) corrected by Fridericia formula (QTcF) of < 440 msec for male and < 460 msec for females.
- Subjects must be right-handed (control for handed-related differences) in lateralized patterns of brain function.
- Ability to identify visual cues during fMRI.
- Subjects' VAS score must be above 20.
Who cannot join
- Subjects who consume more than 28 units of alcohol per week.
- Subjects who test positive for drugs of abuse or alcohol.
- Current use of nicotine replacement therapy or other smoking cessation treatment.
- Use of other investigational drugs within 30 days, or at least 5 half-lives of a study medication prior to enrollment.
- Subjects being treated with other psychotropic drug will be excluded based on PI's clinical judgment and potential drug-drug adverse reactions with study drugs.
- Subjects on prescribed, over-the-counter (OTC) or nutraceutical drugs that may influence the PK, safety or efficacy profiles of MPh-IR and/or Ond-PR002 will be excluded, or receive a washout prior to study enrollment. Subjects on drugs or substances known to be strong inhibitors or strong inducers of CYP 3A4/5 enzymes (enzymes involved in the metabolism of xenobiotics) or P-glycoprotein (P-gp) will be excluded in a similar manner.
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- Subjects with heart disease or uncontrolled high blood pressure.
- Donation of any blood or plasma in the last month, or donation of >500mL of blood within the 3 months preceding study drug administration.
- History of serious adverse reaction or allergies to any drug or any other products used in the study.
- Allergies or intolerance to any of the products used in this study.
- Subjects who have allergies to pork-derived medications or those that contain pork-derived products.
- Inability to give informed consent or high likelihood of being unable to complete the necessary confinement.
- Subjects deemed inappropriate for this study by the Principal Investigator.
- Subjects with a documented brain abnormality, history of unexplained loss of consciousness, seizures, history of unexplained syncope, or history of transient ischemic attack or stroke within the past 6 months.
- History of concurrent illness that required hospitalization within 14 days prior to Day 1 or a clinically significant illness within 4 weeks prior to Day 1.
- History of clinically significant cardiovascular illness within the past 6 months.
- History of clinically significant hepatic, renal, pulmonary, metabolic, endocrine, infectious, gastrointestinal, hematologic, oncologic, retinopathy, or other medical disorders.
- History of unstable psychiatric illness requiring hospitalization within previous 6 months.
- Subjects with history of glaucoma, color blindness or other uncorrected vision problem.
- Subjects with QTcF interval duration greater than or equal to 440 msec (males) or greater than or equal to 460 msec (females) obtained from the 12-lead ECG recorder's measurements on the screening ECG.
- Individuals with a major condition that would make fMRI participation unsafe or uncomfortable.
- Females who are pregnant, breast-feeding or plan on becoming pregnant.
- Subjects who have a hematocrit < 33% or hemoglobin < 12.0 g/dL.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Duke Addictions Clinic
Durham, North Carolina, 27705
Duke Clinical Research Unit
Durham, North Carolina, 27710
SouthLight
Raleigh, North Carolina, 27610
About this study
Official title: PHASE IIA: Randomized, Double Blind, Placebo Controlled, Single Center Clinical Trial of a Combination of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)
The main purpose of this study is to determine the outcome of a drug combination treatment on detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. The combination regimen consists of oral administration of a generic immediate-release methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment tools and functional magnetic resonance imaging (fMRI) will be used to assess the treatment outcome. In addition to the treatment outcome measures, we will determine whether the 14-day, once-a-day treatment leads to significant changes in the pharmacokinetic/pharmacodynamic (PK/PD), safety and tolerability parameters of MPh-IR and/or Ond-PR002 formulations and drug-drug interactions between the two drugs.
- Conditions
- Methamphetamine Dependence, Cocaine Dependence
- Being tested
- OND-PR002 and MPh-IR, Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OND-PR002 and MPh-IRDrug
Also called Ondanasetron, Zofran®, Methylphenidate, Ritalin®
Drug: OND-PR002
Single daily oral doses of 8 mg Ond-PR002
Drug: MPh-IR
Single daily oral doses of 20 mg MPh-IR
Placebo: Two dextrose capsules for Ond-PR002 and MPh-IROther
Also called Placebo
Single daily oral doses
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Other: Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR |
| OND-PR002 and MPh-IR | Experimental | Not described Receives: Drug: OND-PR002 and MPh-IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of combined Ond-PR002 and MPh-IR treatment
Efficacy of combined Ond-PR002 and MPh-IR treatment in reducing the Visual Analogue Scale (VAS), Cocaine Selective Severity Assessment (CSSA) and Amphetamine Cessation Symptom Assessment (ACSA) craving scores in abstinent METH/COC abusers. Changes in cue-reactivity and inhibitory control deficits will be also assessed using functional magnetic resonance imaging (fMRI).
Measured: 15 days
Secondary outcomes (4)
Safety of combined MPh-IR + Ond-PR002 treatment
Number of subjects with clinically significant changes in vital signs, electrocardiogram (ECG), hematology or chemistry panel measurements and number of subjects with self-reported or observed adverse events or serious adverse events will be recorded.
Measured: 15 days
Changes in the PK parameters of Ond-PR002 PK after 14-day treatment
Standard PK parameters of Ond-PR002 (e.g., maximum serum concentrations, time to reach max. concentration, apparent volume of distribution, etc.) will be calculated based on the serum drug concentrations, and statistical differences between Day 1 and Day 14 will be determined.
Measured: 15 days
Changes in the PK parameters of MPh-IR PK after 14-day treatment
Standard PK parameters of MPh-IR on Day 1 and Day 14 will be calculated and statistically compared as described for Ond-PR002.
Measured: 15 days
Tolerability of combined MPh-IR + Ond-PR002 treatment
Number of subjects with clinically significant changes in vital signs, electrocardiogram (ECG), hematology or chemistry panel measurements and number of subjects with self-reported or observed adverse events or serious adverse events will be recorded.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine DependenceStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tong Lee
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Tong Lee, Duke University
- Investigators
- Robert J Noveck, MD,PhD, Principal investigator, Duke Clinical Research UnitAshwin A Patkar, MD, Principal investigator, Psychiatry and Behavioral SciencesTong Lee, MD, PhD, Principal investigator, Associate Professor Psychiatry and Behavorial Science, Duke University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377662
- Sponsor's protocol ID
- Pro00030921
- Other IDs
- 1RC2DA028905-01
- Status last verified
- Sep 2014
- First submitted
- 12 Jun 2011
- Last updated
- 7 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASE IIA: Randomized, Double Blind, Placebo Controlled, Single Center Clinical Trial of a Combination of a Novel Ondansetron Formulation (OND-PR002) and Immediate-Release Methylphenidate (Ritalin®)
- ClinicalTrials.gov ID
- NCT01377662
- Acronym / sponsor ID
- Pro00030921
- Conditions
- Methamphetamine Dependence, Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tong LeeUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 21 Jun 2011 (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.
The main purpose of this study is to determine the outcome of a drug combination treatment on detoxified and stabilized methamphetamine (METH) and/or cocaine (COC) dependent users. The combination regimen consists of oral administration of a generic immediate-release methylphenidate (MPh-IR) formulation (e.g., Ritalin®) and a novel delayed, pulsatile-release formulation of the antiemetic ondansetron (Ond-PR002). Various psychological assessment tools and functional magnetic resonance imaging (fMRI) will be used to assess the treatment outcome. In addition to the treatment outcome measures, we will determine whether the 14-day, once-a-day treatment leads to significant changes in the pharmacokinetic/pharmacodynamic (PK/PD), safety and tolerability parameters of MPh-IR and/or Ond-PR002 formulations and drug-drug interactions between the two drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR |
| OND-PR002 and MPh-IR | Experimental | Drug: OND-PR002 and MPh-IR |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subjects must give written informed consent.
- Detoxified METH/COC-dependent male and/or female subjects between 18 and 45.
- Females with Body Mass Index (BMI) of 18-36 kg/m2. Males with BMI of 20-36 kg/m2.
- Subjects in good health determined by screening examination.
- Subject must have adequate veins for intravenous site.
Key exclusion criteria (23 listed)
- Subjects who consume more than 28 units of alcohol per week.
- Subjects who test positive for drugs of abuse or alcohol.
- Current use of nicotine replacement therapy or other smoking cessation treatment.
- Use of other investigational drugs within 30 days, or at least 5 half-lives of a study medication prior to enrollment.
- Subjects being treated with other psychotropic drug will be excluded based on PI's clinical judgment and potential drug-drug adverse reactions with study drugs.
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 |
|---|---|---|
| OND-PR002 and MPh-IRAlso: Ondanasetron, Zofran®, Methylphenidate, Ritalin®Drug: OND-PR002 Single daily oral doses of 8 mg Ond-PR002 Drug: MPh-IR Single daily oral doses of 20 mg MPh-IR | Drug | OND-PR002 and MPh-IR |
| Placebo: Two dextrose capsules for Ond-PR002 and MPh-IRAlso: PlaceboSingle daily oral doses | Other | Placebo |
Primary outcome
Efficacy of combined Ond-PR002 and MPh-IR treatment
Time frame: 15 days
Efficacy of combined Ond-PR002 and MPh-IR treatment in reducing the Visual Analogue Scale (VAS), Cocaine Selective Severity Assessment (CSSA) and Amphetamine Cessation Symptom Assessment (ACSA) craving scores in abstinent METH/COC abusers. Changes in cue-reactivity and inhibitory control deficits will be also assessed using functional magnetic resonance imaging (fMRI).
4 secondary outcomes
Safety of combined MPh-IR + Ond-PR002 treatment
Time frame: 15 days
Changes in the PK parameters of Ond-PR002 PK after 14-day treatment
Time frame: 15 days
Changes in the PK parameters of MPh-IR PK after 14-day treatment
Time frame: 15 days
Tolerability of combined MPh-IR + Ond-PR002 treatment
Time frame: 15 days
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 7 Oct 2014.
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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.
Robert J Noveck, MD,PhD principal investigator
Duke Clinical Research Unit
Ashwin A Patkar, MD principal investigator
Psychiatry and Behavioral Sciences
Tong Lee, MD, PhD principal investigator
Associate Professor Psychiatry and Behavorial Science, Duke University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OND-PR002 and MPh-IR in people with Methamphetamine Dependence and Cocaine Dependence, run by Tong Lee at 3 sites 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 12 inclusion and 23 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 7 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy of combined Ond-PR002 and MPh-IR treatment (time frame: 15 days). 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 7 Oct 2014.