Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 50 |
| Updated: | 1/13/2017 |
| Start Date: | August 2011 |
| End Date: | June 2012 |
Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers
The study is to primarily measure safety and interactions between oral doses of
Naltrexone/Bupropion and i.v. Methamphetamine.
Naltrexone/Bupropion and i.v. Methamphetamine.
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
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