Ph1 Lobeline Interaction Study - 1

January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)

Double-Blind, Placebo-Controlled, Cross-Over Assessment of Intravenous Methamphetamine and Sublingual Lobeline Interactions

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • Recruiting
        • Langley Porter Psychiatric Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cardiovascular responses

Secondary Outcome Measures

Outcome Measure
Subjective effects

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 22, 2007

First Submitted That Met QC Criteria

February 22, 2007

First Posted (Estimate)

February 23, 2007

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CPU-0012-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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