Pilot Study of Entacapone for Methamphetamine Abuse

NCT ID: NCT02058966

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-06-30

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.

Conditions

Methamphetamine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo followed by Placebo

Subjects will receive placebo, then one hour later, placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

capsules compounded to be of similar appearance to the active drugs

Placebo followed by Methamphetamine

Subjects will receive placebo, then one hour later, methamphetamine

Group Type: EXPERIMENTAL

Methamphetamine

Intervention Type: DRUG

Methamphetamine 20 mg oral dose

Placebo

Intervention Type: DRUG

capsules compounded to be of similar appearance to the active drugs

Entacapone followed by Placebo

Subjects will receive entacapone, then one hour later, placebo

Group Type: EXPERIMENTAL

Entacapone

Intervention Type: DRUG

Entacapone 200 mg oral dose

Placebo

Intervention Type: DRUG

capsules compounded to be of similar appearance to the active drugs

Entacapone followed by Methamphetamine

Subjects will receive entacapone, then one hour later, methamphetamine

Group Type: EXPERIMENTAL

Entacapone

Intervention Type: DRUG

Entacapone 200 mg oral dose

Methamphetamine

Intervention Type: DRUG

Methamphetamine 20 mg oral dose

Interventions

Entacapone

Entacapone 200 mg oral dose

Intervention Type: DRUG

Methamphetamine

Methamphetamine 20 mg oral dose

Intervention Type: DRUG

Placebo

capsules compounded to be of similar appearance to the active drugs

Intervention Type: DRUG

Other Intervention Names

Comtam; Desoxyn

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Portland VA Medical Center

FED

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

William Hoffman

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan C Fellers, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

William F Hoffman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Portland Healthcare System

Locations

Oregon Health & Science University

Portland, Oregon, United States

Countries

United States

Other Identifiers

1004805

Identifier Type: OTHER

Identifier Source: secondary_id

3986

Identifier Type: OTHER

Identifier Source: secondary_id

8874

Identifier Type: -

Identifier Source: org_study_id