Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Completed

CT.gov ID

NCT01359930

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Aug 1, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

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

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

Cardiovascular System Effects [daily during the 10 day treatment period]
Heart rate, blood pressure, ECGs,and monitoring adverse events
Number of subjects with adverse events [Day 0 through Day 10]

Secondary Outcome Measures

Plasma concentrations obtained at specific timepoints [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
Assessment of Vital Signs and Clinical Chemistries [Daily during the 10 day treatment period]
Respiration rate and clinical laboratory measures
Cognitive Assessments as reported by the subject [Dailly during the 10 day treatment period]
Subject reported effects measured with VAS, BSCS, and POMS

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	Langley Porter Psychiatric Institute	San Francisco	California	United States	94143

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Institute on Drug Abuse (NIDA)

ClinicalTrials.gov Identifier:

NCT01359930

Other Study ID Numbers:

NaltrexoneBupropion-Ph1A-met

First Posted:

May 25, 2011

Last Update Posted:

Jan 12, 2017

Last Verified:

Jul 1, 2013

Additional relevant MeSH terms:

Naltrexone

Bupropion

Study Results

No Results Posted as of Jan 12, 2017