Pilot Study of Entacapone for Methamphetamine Abuse

Oregon Health & Science University (OHSU)

Status and phase: Completed; Early Phase 1

Conditions: Methamphetamine Dependence

Treatments: Drug: Methamphetamine; Drug: Placebo; Drug: Entacapone

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02058966

8874

1004805 (Other Identifier)

3986 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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29 participants in 4 patient groups, including a placebo group

Placebo followed by Placebo

Placebo Comparator group

Description:

Subjects will receive placebo, then one hour later, placebo

Treatment:

Drug: Placebo

Placebo followed by Methamphetamine

Experimental group

Description:

Subjects will receive placebo, then one hour later, methamphetamine

Treatment:

Drug: Methamphetamine

Drug: Placebo

Entacapone followed by Placebo

Experimental group

Description:

Subjects will receive entacapone, then one hour later, placebo

Treatment:

Drug: Entacapone

Drug: Placebo

Entacapone followed by Methamphetamine

Experimental group

Description:

Subjects will receive entacapone, then one hour later, methamphetamine

Treatment:

Drug: Entacapone

Drug: Methamphetamine