RTI-336 as a Treatment for Methamphetamine Dependence

NCT01601717 | Withdrawn Phase 1 DMC

• 3 other identifiers: H-251861R01DA027134DPMC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse

Keywords

RTI-336; Methamphetamine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

RTI-336

ACTIVE COMPARATOR

Drug: RTI-336

Interventions

RTI-336 DRUG

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.

RTI-336

Placebo DRUG

Matching placebo pill administered once per day for 10 days.

Also known as: Sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Institute on Drug Abuse (NIDA): collaborator

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

3beta-(4-chlorophenyl) tropane-2beta-(3-(4'-methylphenyl) isoxazol-5-yl) hydrochloride; Sugars

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Richard De La Garza, PhD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor
• Expanded Access: Yes

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: May 18, 2012
• Study Start: January 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 18, 2012

Record last verified: 2012-05