Clinical trial NCT02058966: Pilot Study of Entacapone for Methamphetamine Abuse
Official title: Pilot Study of the Dose Response of Entacapone on Methamphetamine Induced Interest, Mood Elevation, and Reward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Methamphetamine Dependence
Keywords: Entacapone
COMT val158met
Methamphetamine
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Portland VA Medical Center
First posted: 2014-02-11
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Addiction to methamphetamine is a serious health problem. There are no medications that a doctor can give someone to help them stop using methamphetamine. Entacapone (Comtan©) is a medication that could help people addicted to methamphetamine.

This study will see how entacapone works in healthy people who are given methamphetamine. We think that the study drug will be well tolerated, and that it will prevent some of the effects of methamphetamine that make it so addictive. We also want to see how differences in people's genes may cause differences in the ways the study drug and methamphetamine work for them.

The study has six total visits. The first visit is for screening. Tests and procedures will make sure it is safe for subjects to participate.

The second visit is a familiarization day. Subjects will receive methamphetamine, but no entacapone. This is done to make sure they can tolerate the drug and recognize its effects before being given a second drug on the same day. Subjects will take surveys and computer tests to see how the medications change mood, thinking, and liking the drug.

The final four visits are the actual study days. Subjects will be randomly assigned (like the flip of a coin) to the different ways to get either 1) study medication or placebo (placebo contains no active study medication) and then 2) methamphetamine or placebo. Subjects will be in all four groups during the study, which means that each day a subject will get a different group.


Eligibility criteria: Inclusion Criteria:

* No history of pre-existing physical (including cardiovascular) illness
* No history of drug abuse or dependence
* Ability to read and write English
* Have had at least one exposure to a stimulant (e.g. cocaine, methamphetamine, ecstasy, methylphenidate or any medication in the stimulant class) in their lifetime

Exclusion Criteria:

* Pregnant
* Taking any psychotropic medication
* Meeting DSM-IV criteria for active substance abuse or dependence
* On any stimulant medication
* History or current hypertension (BP \> 140/90 mm Hg) or systolic hypotension (SBP \< 90 mm Hg)
* Subjects with resting pulse rate \> 90/min
* Any active medical illness
* Family history of abnormal heart rhythms, or sudden cardiac death
* Subjects who anticipate they may require the emergent use of epinephrine (such as an Epi-Pen®) for the treatment of severe allergic reactions

Primary outcomes:
measure: Effect of Entacapone on Methamphetamine-induced Mood
timeFrame: Measurements acquired before drug ingestion (baseline) then hourly for 4 hours. The peak interaction effect of entacapone and methamphetamine occurs 1 hour after ingestion, therefore the reported values are from this timepoint.
measure: Effect of Entacapone on Subjective Effects of Methamphetamine
timeFrame: Measurements acquired before drug ingestion (baseline) then hourly for 4 hours. The peak interaction effect of entacapone and methamphetamine occurs 1 hour after ingestion, therefore the reported values are from this timepoint.
measure: Effect of Entacapone on Methamphetamine-induced Stimulation
timeFrame: Measurements acquired before drug ingestion (baseline) then hourly for 4 hours. The peak interaction effect of entacapone and methamphetamine occurs 1 hour after ingestion, therefore the reported values are from this timepoint.
Secondary outcomes:
measure: Cognitive Function
timeFrame: Measurements acquired before drug ingestion (baseline) then hourly for 4 hours. The peak interaction effect of entacapone and methamphetamine occurs 1 hour after ingestion, therefore the reported values are from this timepoint.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jonathan C Fellers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Portland Healthcare System
name: William F Hoffman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: