NCT00829634

Brief Summary

The intent of this study is to see if the rate that the body breaks down l-methamphetamine (l-MA) could be used as an accurate estimate for the rate that the body breaks down d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA is the commonly abused form of methamphetamine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

11 months

First QC Date

January 23, 2009

Last Update Submit

May 29, 2013

Conditions

Nasal Congestion

Keywords

methamphetamineinpatientd-MAl-MAAPRLSan FranciscometabolismMetabolism of methamphetamine

Outcome Measures

Primary Outcomes (2)

  • Serum samples

    Predose and Multiple Timepoints Post Doses

  • Urine Samples

    24 Hour Inpatient Collection

Secondary Outcomes (1)

  • Questionnaries

    Predose and Multiple Timepoints Post Doses

Study Arms (1)

l-methamphetamine

OTHER
Drug: l-methamphetamineDrug: d-methamphetamine

Interventions

l-methamphetamineDRUG

5mg of l-methamphetamine per day throughout the 2 week study

Also known as: l-MA
l-methamphetamine
d-methamphetamineDRUG

15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13

Also known as: d-MA
l-methamphetamine

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Males and Females Between the Ages of 18 and 50
  • Must have some experience with methamphetamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPMC Addiction & Pharmacology Research Laboratory (APRL)

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Nasal Obstruction

Interventions

N-myristoyl-alaninol

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

January 23, 2009

First Posted

January 27, 2009

Study Start

October 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

US(1)