Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

National Institutes of Health (NIH)

Status and phase

Completed

Phase 1

Conditions

Methamphetamine Dependence

Treatments

Drug: Naltrexone and Bupropion SR

Other: placebo

Study type

Interventional

Funder types

NIH

Identifiers

NaltrexoneBupropion-Ph1A-met

Details and patient eligibility

About

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

Enrollment

16 estimated patients

Sex

All

Ages

21 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.