RTI-336 as a Treatment for Methamphetamine Dependence

• Status: Withdrawn
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Methamphetamine

Criteria

Inclusion Criteria:

In order to participate in the study, participants must:

1. Be English-speaking volunteers who are not seeking abstinence-focused treatment at the time of the study.

2. Be between 18-55 years of age.

3. Meet DSM-IV-TR criteria for METH dependence.

4. Self-report that preferred route of METH use is intravenous.

5. Have vital signs as follows: resting pulse between 50-90 bpm, blood pressure between 85-150 mmHg systolic and 45-90 mmHg diastolic.

6. Have a breathalyzer test indicating an undetectable blood alcohol level upon admission.

7. 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

8. Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias.

9. 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.

10. Weigh between 60 and 100 kg.

Exclusion Criteria:

Potential participants will be excluded from participation in the study if any of the following apply:

1. Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure.

2. 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.

3. Meet DSM-IV criteria for abuse/dependence on alcohol or other drugs, except nicotine or marijuana.

4. Have evidence of clinically significant heart disease or hypertension, as determined by physician.

5. Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease.

6. Have HIV and currently symptomatic, have a diagnosis of AIDS, or currently taking antiretroviral medication.

7. 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.

8. Have any history of asthma, chronic coughing and wheezing, or other chronic respiratory illnesses.

9. Currently use alpha or beta agonists, theophylline, or other sympathomimetics.

10. 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.