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NCT00439504 Clinical Trial

Ph1 Lobeline Interaction Study - 1

Methamphetamine Dependence Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT00439504
Other study ID # NIDA-CPU-0012-1
Secondary ID
Status Unknown status
Phase Phase 1
First received February 22, 2007
Last updated January 10, 2017

Study information
Verified date February 2007
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Unknown status
Enrollment 10
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Lobeline

Locations
Country Name City State
United States Langley Porter Psychiatric Institute San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiovascular responses
Secondary Subjective effects
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