Ph1 Lobeline Interaction Study - 1

Sponsor
National Institute on Drug Abuse (NIDA) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT00439504
Collaborator
(none)
10
1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Double-Blind, Placebo-Controlled, Cross-Over Assessment of Intravenous Methamphetamine and Sublingual Lobeline Interactions

Outcome Measures

Primary Outcome Measures

  1. Cardiovascular responses []

Secondary Outcome Measures

  1. Subjective effects []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • Please contact site for details

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

  • Principal Investigator: Reese Jones, M.D., Langley Porter Psychiatric Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00439504
Other Study ID Numbers:
  • NIDA-CPU-0012-1
First Posted:
Feb 23, 2007
Last Update Posted:
Jan 11, 2017
Last Verified:
Feb 1, 2007
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2017