Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study
Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers
1 other identifier
interventional
16
1 country
1
Brief Summary
The study is to primarily measure safety and interactions between oral doses of Naltrexone/Bupropion and i.v. Methamphetamine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 25, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJanuary 12, 2017
July 1, 2013
10 months
May 18, 2011
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Plasma concentrations obtained at specific timepoints
daily during the 10 day treatment period
Assessment of Vital Signs and Clinical Chemistries
Daily during the 10 day treatment period
Cognitive Assessments as reported by the subject
Dailly during the 10 day treatment period
Study Arms (2)
Naltrexone and Bupropion SR
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Please contact site for more information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Langley Porter Psychiatric Institute
San Francisco, California, 94143, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 25, 2011
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
January 12, 2017
Record last verified: 2013-07