Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

Study Overview
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Brief Summary
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The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.

Official Title
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Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers

Conditions
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Methamphetamine Dependence

Intervention / Treatment
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* Other: placebo
* Drug: Naltrexone and Bupropion SR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are MA experienced but not dependent, males or females aged 21-to-50 years. Reported use of MA during the past six months without experiencing an adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use. Have a body mass index (BMI) between 18 and 30. Are willing and able to give written consent. Are not currently a subject (including still in the follow-up period) of another drug research study. Have no medical contraindications determined by the following: an adequate medical history, a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis. Have a negative drug test for barbiturates, benzodiazepines, opiates, cocaine, amphetamines and ethanol at the time of hospital admission (Day 0). Are females who have a negative pregnancy test at hospital admission. Are of either non-childbearing (tubal ligation or total hysterectomy) or of childbearing potential using one or more of the following barrier methods of contraception: male or female condoms (with/without spermicide), diaphragm (with spermicide) and/or copper containing intrauterine device (with/without spermicide). No other contraceptives are acceptable. Exclusion Criteria: Please contact site for more information

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Naltrexone and Bupropion SR<br> | Drug: Naltrexone and Bupropion SR<br>* 25mg bid/day (NX) 200mg bid/day (BUP)<br>|
| Placebo Comparator: Placebo<br> | Other: placebo<br>* matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular System Effects | Heart rate, blood pressure, ECGs,and monitoring adverse events | daily during the 10 day treatment period | 
| Number of subjects with adverse events |  | Day 0 through Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations obtained at specific timepoints | PK of IV (meth) and its metabolites before and during Naltrexone/BUP exposure PK of bupropion, naltrexone and their metabolites | daily during the 10 day treatment period | 
| Assessment of Vital Signs and Clinical Chemistries | Respiration rate and clinical laboratory measures | Daily during the 10 day treatment period | 
| Cognitive Assessments as reported by the subject | Subject reported effects measured with VAS, BSCS, and POMS | Dailly during the 10 day treatment period |