Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01359930

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) 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:
Bupropion hydrochloride, naltrexone hydrochoride drug combination
Adrenergic Agents
Adrenergic Uptake Inhibitors
Anti-Obesity Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Autonomic Agents
Central Nervous System Stimulants
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Sympathomimetics processed this record on May 24, 2016