- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02058966
Pilot Study of Entacapone for Methamphetamine Abuse
Pilot Study of the Dose Response of Entacapone on Methamphetamine Induced Interest, Mood Elevation, and Reward
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Oregon Health & Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo followed by Placebo
Subjects will receive placebo, then one hour later, placebo
|
capsules compounded to be of similar appearance to the active drugs
|
Experimental: Placebo followed by Methamphetamine
Subjects will receive placebo, then one hour later, methamphetamine
|
capsules compounded to be of similar appearance to the active drugs
Methamphetamine 20 mg oral dose
Other Names:
|
Experimental: Entacapone followed by Placebo
Subjects will receive entacapone, then one hour later, placebo
|
capsules compounded to be of similar appearance to the active drugs
Entacapone 200 mg oral dose
Other Names:
|
Experimental: Entacapone followed by Methamphetamine
Subjects will receive entacapone, then one hour later, methamphetamine
|
Methamphetamine 20 mg oral dose
Other Names:
Entacapone 200 mg oral dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of Entacapone on Methamphetamine-induced Mood
Time Frame: 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.
|
Profile of Mood States is a 65 item questionnaire using a Likert rating scale to assess transient, distinct moods.
The questionnaire contains 65 words/statements that describe feelings people have.
The test requires you to indicate for each word or statement how you have been feeling in the past week including today.
A Total Mood Disturbance score is calculated by adding scores for Tension, Depression, Anger, Fatigue and Confusion and then subtracting the Vigour score.
The Total Mood Disturbance scale ranges from -32 to 200 with lower scores indicative of people with more stable mood profiles.
|
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.
|
Effect of Entacapone on Subjective Effects of Methamphetamine
Time Frame: 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.
|
The subjective effects of the study drug were evaluated with the Addiction Research Center Inventory (ARCI-49), a 49 item questionnaire consisting of true/false items.
True items receive a score of 1 if answer is 'True', false items receive a score of 1 if answer is 'False'.
No points are given when answer is opposite to scoring direction.
There are 5 subscales: Morphine Benzedrine group scale to measure euphoria (range: 0-16 with higher numbers indicating more euphoria), A Lysergic Acid Diethylamide group scale to estimate dysphoria and agitation (range: 0-14 with higher scores indicating more dysphoria), a Pentobarbital Chlorpromazine Alcohol group scale to measure sedation (range: 0-15 with higher scores indicating more sedation), and a Benzedrine group scale and an Amphetamine Scale to assess stimulant effects (range: 0-13 and 0-11, respectively, with higher scores indicating higher stimulant effects) .
|
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.
|
Effect of Entacapone on Methamphetamine-induced Stimulation
Time Frame: 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.
|
The Global Rating of Stimulation is a 1-item question "I feel light-headed, restless, or speeded-up" in which the participant is asked to circle one answer on a scale from 0-4, 0 is 'normal', 1 is 'slightly', 2 is 'moderately', 3 is 'very much', and 4 is 'extremely'.
Whichever number they circled is their reported score.
A higher score is indicative of a greater stimulating effect.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognitive Function
Time Frame: 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.
|
Two computer tests were administered to measure how each medication intervention effects cognitive functioning.
The tests administered included the Rapid Visual Information Processing Task (RVIPT), a 6 minute test of sustained attention in which participants are requested to detect target sequences of digits and the Digit Symbol Substitution Task (DSST), a 2 minute test of psychomotor speed and sustained attention consisting of digit-symbol pairs followed by a list of digits where the subject identifies the symbol that corresponds to each digit as fast as possible.
The number of correct responses within the allowed time is measured.
Higher scores on both tasks indicate better performance.
|
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.
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jonathan C Fellers, MD, Oregon Health and Science University
- Principal Investigator: William F Hoffman, MD, PhD, VA Portland Healthcare System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Antiparkinson Agents
- Anti-Dyskinesia Agents
- Catechol O-Methyltransferase Inhibitors
- Methamphetamine
- Entacapone
Other Study ID Numbers
- 8874
- 1004805 (Other Identifier: OHSU InfoEd)
- 3986 (OCTRI)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Methamphetamine Dependence
-
University of California, Los AngelesCompletedMethamphetamine Dependence in Remission | Continuous Methamphetamine Dependence
-
National Institute on Drug Abuse (NIDA)Not yet recruitingMethamphetamine-dependence | Methamphetamine Abuse
-
InterveXion Therapeutics, LLCNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine-dependence | Methamphetamine AbuseUnited States
-
Centre for Addiction and Mental HealthNot yet recruitingMethamphetamine-dependence | Methamphetamine AbuseCanada
-
InterveXion Therapeutics, LLCNational Institute on Drug Abuse (NIDA)Active, not recruitingMethamphetamine-dependence | Methamphetamine AbuseUnited States
-
University of ArkansasCompletedCharacterizing Methamphetamine Withdrawal in Recently Abstinent Methamphetamine Users: A Pilot StudyMethamphetamine Dependence | Methamphetamine WithdrawalUnited States
-
University of KentuckyNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Dependence | Methamphetamine AbuseUnited States
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA)TerminatedMethamphetamine Dependence | Methamphetamine AbuseUnited States
-
University of CincinnatiNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Dependence | Methamphetamine AbuseUnited States, Canada
-
University of KentuckyNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Dependence | Methamphetamine AbuseUnited States
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States