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Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

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ClinicalTrials.gov Identifier: NCT01359930
Recruitment Status : Completed
First Posted : May 25, 2011
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence Other: placebo Drug: Naltrexone and Bupropion SR Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Phase 1 Study of Interactions Between Oral Naltrexone and Bupropion and Intravenous Methamphetamine in Methamphetamine Experienced Volunteers
Study Start Date : August 2011
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01359930


Locations
United States, California
Langley Porter Psychiatric Institute
San Francisco, California, United States, 94143
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
More Information

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01359930     History of Changes
Other Study ID Numbers: NaltrexoneBupropion-Ph1A-met
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: July 2013

Additional relevant MeSH terms:
Naltrexone
Methamphetamine
Bupropion
Bupropion hydrochloride, naltrexone hydrochoride drug combination
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Central Nervous System Stimulants
Sympathomimetics
Autonomic Agents
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Obesity Agents