Methamphetamine DependencePhase 1NCT01601717
RTI-336 as a Treatment for Methamphetamine Dependence
A Phase 1 study testing RTI-336 in people with Methamphetamine Dependence and Substance Abuse, run by Baylor College of Medicine.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of RTI-336 as a treatment for methamphetamine (METH) dependence in non-treatment-seeking METH-dependent volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Methamphetamine Dependence, Substance Abuse, Methamphetamine Abuse
- What is being tested?
- RTI-336
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2012
- 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
- In order to participate in the study, participants must:
- Be English-speaking volunteers who are not seeking abstinence-focused treatment at the time of the study.
- Be between 18-55 years of age.
- Meet DSM-IV-TR criteria for METH dependence.
- Self-report that preferred route of METH use is intravenous.
- Have vital signs as follows: resting pulse between 50-90 bpm, blood pressure between 85-150 mmHg systolic and 45-90 mmHg diastolic.
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- Have a breathalyzer test indicating an undetectable blood alcohol level upon admission.
- Have hematology and chemistry laboratory tests that are within normal ("b10%) limits with the following exceptions: Liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal; Kidney function tests (creatinine and BUN) < 2 x the upper limit of normal
- Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias.
- Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.
- Weigh between 60 and 100 kg.
Who cannot join
- Potential participants will be excluded from participation in the study if any of the following apply:
- Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure.
- Have neurological or psychiatric disorders, as assessed by MINI, such as: episode of major depression within the past 2 years; lifetime history of schizophrenia, other psychotic illness, or bipolar illness; current organic brain disease or dementia assessed by clinical interview; history of or any current psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of suicide attempts within the past three months and/or current suicidal ideation/plan; history of psychosis occurring in the absence of current METH use.
- Meet DSM-IV criteria for abuse/dependence on alcohol or other drugs, except nicotine or marijuana.
- Have evidence of clinically significant heart disease or hypertension, as determined by physician.
- Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease.
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- Have HIV and currently symptomatic, have a diagnosis of AIDS, or currently taking antiretroviral medication.
- Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, and throughout the study.
- Have any history of asthma, chronic coughing and wheezing, or other chronic respiratory illnesses.
- Currently use alpha or beta agonists, theophylline, or other sympathomimetics.
- Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of study.
About this study
Official title: RTI-336 for Methamphetamine Dependence
The purpose of this study is to evaluate the safety and efficacy of RTI-336 as a treatment for methamphetamine (METH) dependence in non-treatment-seeking METH-dependent volunteers.
Read the detailed description
Methamphetamine (METH) is a highly addictive stimulant and acute exposure causes dopamine (DA) release and stimulates midbrain reward centers. The proposed work represents an important research effort with considerable public health significance in that it will evaluate a compound targeted specifically at DA transporter (DAT) inhibition for the treatment of METH dependence. The knowledge gained may ultimately support development and implementation of evidence-based treatments for METH dependence, a drug abuse problem with tremendous public health impact.
One therapeutic strategy is to develop and test compounds that normalize (increase) DA to determine if treatment with these drugs reduces METH use. A similar approach has been proposed as a treatment for cocaine dependence (Howell and Wilcox 2001; Mello and Negus 1996), another disorder associated with abnormally low DA activity (Martinez et al. 2007). In an effort to identify a DAT selective inhibitor, a number of 3-phenyltropane analogs were synthesized by RTI International. Among these, preclinical studies have shown that RTI-336 produced cocaine-like discriminative stimulus effects and reduced cocaine self-administration in rats, and produced dose-dependent suppression of cocaine self-administration in rhesus monkeys.
RTI-336 recently received IND-approval (75,778) for preliminary safety testing in healthy male volunteers, and is scheduled to be completed by February 2009. Subsequent to this effort, RTI-336 will be evaluated in a phase I trial involving cocaine-dependent volunteers. The current application puts forth, for the first time, a proposal to evaluate the preliminary efficacy of this very promising candidate medication in non-treatment-seeking METH-dependent volunteers.
- Being tested
- RTI-336, Placebo
- Keywords
- RTI-336, Methamphetamine
- 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.
RTI-336Drug
Four medication dosage groups (0 mg, 1 mg, 12 mg, 20 mg) administered in the form of a pill once per day for 10 days.
PlaceboDrug
Also called Sugar pill
Matching placebo pill administered once per day for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo |
| RTI-336 | Active comparator | Not described Receives: Drug: RTI-336 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effects of RTI-336 and methamphetamine on cardiovascular measures
Before and after each methamphetamine infusion during treatment with RTI-336, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on RTI-336 relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
Secondary outcomes (1)
The effects of RTI-336 and methamphetamine on subjective measures
The ability of RTI-336 (1, 12 or 20 mg), as compared to placebo, to attenuate METH-induced (0 and 50 mg, IV) positive subjective effects (craving and ability to reduce reinforcing effects produced by methamphetamine) will be measured by: 1. VAS, Adjective Scales, and MCQ; 2. Choices for methamphetamine vs. money in the self-administration assay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJan 2012
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.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Richard De La Garza, Baylor College of Medicine
- Investigators
- Richard De La Garza, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601717
- Sponsor's protocol ID
- H-25186
- Other IDs
- 1R01DA027134, DPMC
- Status last verified
- May 2012
- First submitted
- 10 Dec 2009
- Last updated
- 18 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RTI-336 for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT01601717
- Acronym / sponsor ID
- H-25186
- Keywords
- RTI-336, Methamphetamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 18 May 2012 (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 purpose of this study is to evaluate the safety and efficacy of RTI-336 as a treatment for methamphetamine (METH) dependence in non-treatment-seeking METH-dependent volunteers.
Detailed description
Methamphetamine (METH) is a highly addictive stimulant and acute exposure causes dopamine (DA) release and stimulates midbrain reward centers. The proposed work represents an important research effort with considerable public health significance in that it will evaluate a compound targeted specifically at DA transporter (DAT) inhibition for the treatment of METH dependence. The knowledge gained may ultimately support development and implementation of evidence-based treatments for METH dependence, a drug abuse problem with tremendous public health impact.
One therapeutic strategy is to develop and test compounds that normalize (increase) DA to determine if treatment with these drugs reduces METH use. A similar approach has been proposed as a treatment for cocaine dependence (Howell and Wilcox 2001; Mello and Negus 1996), another disorder associated with abnormally low DA activity (Martinez et al. 2007). In an effort to identify a DAT selective inhibitor, a number of 3-phenyltropane analogs were synthesized by RTI International. Among these, preclinical studies have shown that RTI-336 produced cocaine-like discriminative stimulus effects and reduced cocaine self-administration in rats, and produced dose-dependent suppression of cocaine self-administration in rhesus monkeys.
RTI-336 recently received IND-approval (75,778) for preliminary safety testing in healthy male volunteers, and is scheduled to be completed by February 2009. Subsequent to this effort, RTI-336 will be evaluated in a phase I trial involving cocaine-dependent volunteers. The current application puts forth, for the first time, a proposal to evaluate the preliminary efficacy of this very promising candidate medication in non-treatment-seeking METH-dependent volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sugar pill | Placebo comparator | Drug: Placebo |
| RTI-336 | Active comparator | Drug: RTI-336 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Be English-speaking volunteers who are not seeking abstinence-focused treatment at the time of the study.
- Be between 18-55 years of age.
- Meet DSM-IV-TR criteria for METH dependence.
- Self-report that preferred route of METH use is intravenous.
- Have vital signs as follows: resting pulse between 50-90 bpm, blood pressure between 85-150 mmHg systolic and 45-90 mmHg diastolic.
Key exclusion criteria (11 listed)
- Potential participants will be excluded from participation in the study if any of the following apply:
- Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure.
- Have neurological or psychiatric disorders, as assessed by MINI, such as: episode of major depression within the past 2 years; lifetime history of schizophrenia, other psychotic illness, or bipolar illness; current organic brain disease or dementia assessed by clinical interview; history of or any current psychiatric disorder which would require ongoing treatment or which would make study compliance difficult; history of suicide attempts within the past three months and/or current suicidal ideation/plan; history of psychosis occurring in the absence of current METH use.
- Meet DSM-IV criteria for abuse/dependence on alcohol or other drugs, except nicotine or marijuana.
- Have evidence of clinically significant heart disease or hypertension, as determined by physician.
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 |
|---|---|---|
| RTI-336Four medication dosage groups (0 mg, 1 mg, 12 mg, 20 mg) administered in the form of a pill once per day for 10 days. | Drug | RTI-336 |
| PlaceboAlso: Sugar pillMatching placebo pill administered once per day for 10 days. | Drug | Sugar pill |
Primary outcome
The effects of RTI-336 and methamphetamine on cardiovascular measures
Before and after each methamphetamine infusion during treatment with RTI-336, physiologic responses will be closely monitored using repeated HR, BP, and ECG readings. To evaluate safety, a DSMB will meet annually and following any serious AE to examine data as well as any new published information on RTI-336 relevant to the project. The number of AEs (including arrhythmias and ECG changes), changes in BP and HR, and changes in mood and psychiatric symptoms (using the BSI, BDI, POMS, and BPRS) will also be assessed throughout the study.
1 secondary outcome
The effects of RTI-336 and methamphetamine on subjective measures
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
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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.
Richard De La Garza, PhD principal investigator
Baylor College of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RTI-336 in people with Methamphetamine Dependence and Substance Abuse, run by Baylor College of Medicine.
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 11 inclusion and 11 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: withdrawn, as of the sponsor's last update on 18 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
The effects of RTI-336 and methamphetamine on cardiovascular measures. 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 18 May 2012.