Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

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.

Study Overview

• Status: Completed
• Conditions: Methamphetamine Dependence
• Intervention / Treatment: Other: placebo; Drug: Naltrexone and Bupropion SR

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Langley Porter Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: placebo; matching placebo
ACTIVE_COMPARATOR: Naltrexone and Bupropion SR	Drug: Naltrexone and Bupropion SR; 25mg bid/day (NX) 200mg bid/day (BUP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentrations obtained at specific timepoints	PK of IV (meth) and its metabolites before and during Naltrexone/BUP exposure; PK of bupropion, naltrexone and their metabolites	daily during the 10 day treatment period
Assessment of Vital Signs and Clinical Chemistries	Respiration rate and clinical laboratory measures	Daily during the 10 day treatment period
Cognitive Assessments as reported by the subject	Subject reported effects measured with VAS, BSCS, and POMS	Dailly during the 10 day treatment period

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (ACTUAL): June 1, 2012
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: May 18, 2011
• First Submitted That Met QC Criteria: May 23, 2011
• First Posted (ESTIMATE): May 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 12, 2017
• Last Update Submitted That Met QC Criteria: January 11, 2017
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Narcotic Antagonists; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Alcohol Deterrents; Dopamine Uptake Inhibitors; Naltrexone; Bupropion
• Other Study ID Numbers: NaltrexoneBupropion-Ph1A-met