Methamphetamine Dependence
Conditions
Brief summary
The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
Interventions
25mg bid/day (NX) 200mg bid/day (BUP)
OTHERplacebo
matching placebo
Sponsors
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular System Effects | daily during the 10 day treatment period | Heart rate, blood pressure, ECGs,and monitoring adverse events |
| Number of subjects with adverse events | Day 0 through Day 10 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma concentrations obtained at specific timepoints | daily during the 10 day treatment period | * PK of IV (meth) and its metabolites before and during Naltrexone/BUP exposure * PK of bupropion, naltrexone and their metabolites |
| Assessment of Vital Signs and Clinical Chemistries | Daily during the 10 day treatment period | Respiration rate and clinical laboratory measures |
| Cognitive Assessments as reported by the subject | Dailly during the 10 day treatment period | Subject reported effects measured with VAS, BSCS, and POMS |
Countries
United States
Outcome results
None listed