Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study
Phase 1
Completed
- Conditions
- Methamphetamine Dependence
- Interventions
- Other: placebo
- Registration Number
- NCT01359930
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- Brief Summary
The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo placebo - Naltrexone and Bupropion SR Naltrexone and Bupropion SR -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Cognitive Assessments as reported by the subject Dailly during the 10 day treatment period Subject reported effects measured with VAS, BSCS, and POMS
Assessment of Vital Signs and Clinical Chemistries Daily during the 10 day treatment period Respiration rate and clinical laboratory measures
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
Trial Locations
- Locations (1)
Langley Porter Psychiatric Institute
🇺🇸San Francisco, California, United States