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Ph1 Lobeline Interaction Study - 1

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00439504
Enrollment
10
Registered
2007-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Methamphetamine Dependence

Brief summary

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

Interventions

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
Cardiovascular responses

Secondary

MeasureTime frame
Subjective effects

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026