NCT00439504

Brief Summary

The purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
Last Updated

January 11, 2017

Status Verified

February 1, 2007

First QC Date

February 22, 2007

Last Update Submit

January 10, 2017

Conditions

Methamphetamine Dependence

Outcome Measures

Primary Outcomes (1)

  • Cardiovascular responses

Secondary Outcomes (1)

  • Subjective effects

Interventions

LobelineDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18 and 45 years of age
  • Be in general good health with a history of methamphetamine (MA) abuse (but not dependence)
  • If female and of child bearing potential, agrees to use birth control
  • Be able to understand and provide written informed consent
  • Have a body mass index between 18 and 30
  • Have reported use of (MA) during the past three months without experiencing adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use
  • Have a negative drug test (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids, ethanol) at screening and at the time of admission

You may not qualify if:

  • Please contact site for details

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Langley Porter Psychiatric Institute

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Interventions

Lobeline

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Reese Jones, M.D.

    Langley Porter Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 23, 2007

Last Updated

January 11, 2017

Record last verified: 2007-02

Locations

US(1)