Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

Methamphetamine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359930
• Other study ID #: NaltrexoneBupropion-Ph1A-met
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2011
• Last updated: January 11, 2017
• Start date: August 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2013
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

Other:
• placebo
matching placebo

Drug:
• Naltrexone and Bupropion SR
25mg bid/day (NX) 200mg bid/day (BUP)

Locations

Country	Name	City	State
United States	Langley Porter Psychiatric Institute	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular System Effects	Heart rate, blood pressure, ECGs,and monitoring adverse events	daily during the 10 day treatment period	Yes
Primary	Number of subjects with adverse events		Day 0 through Day 10	Yes
Secondary	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	No
Secondary	Assessment of Vital Signs and Clinical Chemistries	Respiration rate and clinical laboratory measures	Daily during the 10 day treatment period	Yes
Secondary	Cognitive Assessments as reported by the subject	Subject reported effects measured with VAS, BSCS, and POMS	Dailly during the 10 day treatment period	No