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Completed

NCT Number: NCT00569374

Safety and Tolerability of Modafinil for Methamphetamine Dependence

This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.

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Key information

Conditions

Methamphetamine Dependence

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years old
  • not currently enrolled in a treatment program
  • subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during the month prior to study entry
  • subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
  • women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study

Exclusion criteria

  • current diagnosis of alcohol, opiate, or sedative physical dependence
  • ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
  • history of schizophrenia, or bipolar type I disorder
  • present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
  • medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine, or desipramine)
  • Current suicidality or psychosis
  • liver function tests (i.e., liver enzymes) greater than three times normal levels
  • pregnancy or breastfeeding

Treatment and study plan

Modafinil

Drug

subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7

Primary outcomes

  1. Heart Rate

    Time frame: Thrice weekly for 7 weeks

    Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.

  2. Systolic Blood Pressure

    Time frame: Thrice weekly for 7 weeks

    Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.

  3. Diastolic Blood Pressure

    Time frame: Thrice weekly for 7 weeks

    Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.

  4. "Modafinil Side Effects Checklist"

    Time frame: Weekly for 7 weeks

    Modafinil side effects were measured weekly by means of the Modafinil Side Effects Checklist which asked participants to rate their experience of the following potential side effects: headaches, nausea, nervousness, runny nose, diarrhea, back pain, anxiety, insomnia, dizziness and upset stomach. Participants rated their experience on a 4 point scale ranging from "not at all" (0) to "very much (4). The score was determined by units on a scale.

  5. Anxiety as Measured by the Hamilton Anxiety Scale

    Time frame: Thrice weekly for 7 weeks

    Participants were administered the Hamilton Anxiety Scale thrice weekly throughout the study. The scale is a 14 item questionaire with scores ranging from 0 to 56.

  6. Depression as Measured by the Hamilton Depression Scale

    Time frame: Thrice weekly for 7 weeks

    Participants were administered the Hamilton Depression Scale thrice weekly throughout the study. The scale is a 21 item questionaire with scores ranging from 0 to 62 with a cutoff for depression of 15.

Secondary outcomes

  1. Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.

    Time frame: Thrice weekly for the first three weeks

    The Amphetamine Withdrawal Questionaire was given at intake and 3 times weekly during the first 3 weeks of the study. This time span was chosen due to the tendency of methamphetamine withdrawal to enter an acute phase in the first week after last use with a subsequent subacute phase following for the next two weeks(McGregor et al, 2005). This questionaire is comprised of 10 items which describe symptoms associated with the cessation of chronic amphetamine use for which participants indicate severity on a 4-point scale. The minimum score is 0 and the maximum score is 40.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2007
Primary completion
2008
First posted
Dec 7, 2007
Registry last updated
Oct 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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