Skip to main content
OpenTrials
Completed

NCT Number: NCT01359930

Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Methamphetamine Dependence

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Langley Porter Psychiatric Institute

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Other

matching placebo

naltrexone and bupropion SR

Drug

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

Primary outcomes

  1. Cardiovascular System Effects

    Time frame: daily during the 10 day treatment period

    Heart rate, blood pressure, ECGs,and monitoring adverse events

  2. Number of subjects with adverse events

    Time frame: Day 0 through Day 10

Secondary outcomes

  1. Plasma concentrations obtained at specific timepoints

    Time frame: 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

  2. Assessment of Vital Signs and Clinical Chemistries

    Time frame: Daily during the 10 day treatment period

    Respiration rate and clinical laboratory measures

  3. Cognitive Assessments as reported by the subject

    Time frame: Dailly during the 10 day treatment period

    Subject reported effects measured with VAS, BSCS, and POMS

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 25, 2011
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.