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Pilot Study of Entacapone for Methamphetamine Abuse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02058966
Recruitment Status : Completed
First Posted : February 11, 2014
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Portland VA Medical Center
Information provided by (Responsible Party):
William Hoffman, Oregon Health and Science University

Tracking Information
First Submitted Date  ICMJE February 5, 2014
First Posted Date  ICMJE February 11, 2014
Results First Submitted Date  ICMJE February 14, 2017
Results First Posted Date  ICMJE September 12, 2019
Last Update Posted Date September 12, 2019
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • 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.
  • 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) .
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Interest, Mood elevation, and Reward [ Time Frame: Within 4 hours ]
As measured by self-report surveys
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2014)
Cognition [ Time Frame: Within 4 hours ]
As measured by computer-based assessments
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 6, 2014)
Pharmacokinetic Outcome Measures (AUC) [ Time Frame: 0.5, 1, 1.5, 2, 3, 4 hours post first study drug dose ]
Area under the plasma concentration versus time curve (AUC) for both entacapone and methamphetamine at six different time points
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Entacapone for Methamphetamine Abuse
Official Title  ICMJE Pilot Study of the Dose Response of Entacapone on Methamphetamine Induced Interest, Mood Elevation, and Reward
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Methamphetamine Dependence
Intervention  ICMJE
  • Drug: Entacapone
    Entacapone 200 mg oral dose
    Other Name: Comtam
  • Drug: Methamphetamine
    Methamphetamine 20 mg oral dose
    Other Name: Desoxyn
  • Drug: Placebo
    capsules compounded to be of similar appearance to the active drugs
Study Arms  ICMJE
  • Placebo Comparator: Placebo followed by Placebo
    Subjects will receive placebo, then one hour later, placebo
    Intervention: Drug: Placebo
  • Experimental: Placebo followed by Methamphetamine
    Subjects will receive placebo, then one hour later, methamphetamine
    Interventions:
    • Drug: Methamphetamine
    • Drug: Placebo
  • Experimental: Entacapone followed by Placebo
    Subjects will receive entacapone, then one hour later, placebo
    Interventions:
    • Drug: Entacapone
    • Drug: Placebo
  • Experimental: Entacapone followed by Methamphetamine
    Subjects will receive entacapone, then one hour later, methamphetamine
    Interventions:
    • Drug: Entacapone
    • Drug: Methamphetamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2016)
29
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2014)
32
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02058966
Other Study ID Numbers  ICMJE 8874
1004805 ( Other Identifier: OHSU InfoEd )
3986 ( Other Identifier: OCTRI )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party William Hoffman, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Portland VA Medical Center
Investigators  ICMJE
Principal Investigator: Jonathan C Fellers, MD Oregon Health and Science University
Principal Investigator: William F Hoffman, MD, PhD VA Portland Healthcare System
PRS Account Oregon Health and Science University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP