Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT01359930
First received: May 18, 2011
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Methamphetamine Dependence
Other: placebo
Drug: Naltrexone and Bupropion SR
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Cardiovascular System Effects [ Time Frame: daily during the 10 day treatment period ] [ Designated as safety issue: Yes ]
    Heart rate, blood pressure, ECGs,and monitoring adverse events

  • Number of subjects with adverse events [ Time Frame: Day 0 through Day 10 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations obtained at specific timepoints [ Time Frame: daily during the 10 day treatment period ] [ Designated as safety issue: No ]
    • PK of IV (meth) and its metabolites before and during Naltrexone/BUP exposure
    • PK of bupropion, naltrexone and their metabolites

  • Assessment of Vital Signs and Clinical Chemistries [ Time Frame: Daily during the 10 day treatment period ] [ Designated as safety issue: Yes ]
    Respiration rate and clinical laboratory measures

  • Cognitive Assessments as reported by the subject [ Time Frame: Dailly during the 10 day treatment period ] [ Designated as safety issue: No ]
    Subject reported effects measured with VAS, BSCS, and POMS


Estimated Enrollment: 16
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Naltrexone and Bupropion SR Drug: Naltrexone and Bupropion SR
25mg bid/day (NX) 200mg bid/day (BUP)
Placebo Comparator: Placebo Other: placebo
matching placebo

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01359930

Locations
United States, California
Langley Porter Psychiatric Institute
San Francisco, California, United States, 94143
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01359930     History of Changes
Other Study ID Numbers: NaltrexoneBupropion-Ph1A-met
Study First Received: May 18, 2011
Last Updated: July 1, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Naltrexone
Methamphetamine
Bupropion
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 22, 2014