Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Methamphetamine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Naltrexone and Bupropion SR

Group Type ACTIVE_COMPARATOR

Naltrexone and Bupropion SR

Intervention Type DRUG

25mg bid/day (NX) 200mg bid/day (BUP)

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

matching placebo

Interventions

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placebo

matching placebo

Intervention Type OTHER

Naltrexone and Bupropion SR

25mg bid/day (NX) 200mg bid/day (BUP)

Intervention Type DRUG

Eligibility Criteria

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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.