Safety and Tolerability of Modafinil for Methamphetamine Dependence - Full Text View

Sponsor:	University of Arkansas
Collaborator:	National Institute on Drug Abuse (NIDA)
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00569374

Purpose

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.

Condition	Intervention	Phase
Methamphetamine Dependence	Drug: Modafinil	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Safety and Tolerability of Modafinil for Methamphetamine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Depression Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Modafinil Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Heart Rate [ Time Frame: Thrice weekly for 7 weeks ] [ Designated as safety issue: Yes ]
Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.
Systolic Blood Pressure [ Time Frame: Thrice weekly for 7 weeks ] [ Designated as safety issue: Yes ]
Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Diastolic Blood Pressure [ Time Frame: Thrice weekly for 7 weeks ] [ Designated as safety issue: Yes ]
Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
"Modafinil Side Effects Checklist" [ Time Frame: Weekly for 7 weeks ] [ Designated as safety issue: Yes ]
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.
Anxiety as Measured by the Hamilton Anxiety Scale [ Time Frame: Thrice weekly for 7 weeks ] [ Designated as safety issue: Yes ]
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.
Depression as Measured by the Hamilton Depression Scale [ Time Frame: Thrice weekly for 7 weeks ] [ Designated as safety issue: Yes ]
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 Outcome Measures:

Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire. [ Time Frame: Thrice weekly for the first three weeks ] [ Designated as safety issue: No ]
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.

Enrollment:	8
Study Start Date:	September 2007
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569374

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Dr. Janette McGaugh, MD

University of Arkansas

More Information

No publications provided

Responsible Party:	Carole Hamon, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier:	NCT00569374 History of Changes
Other Study ID Numbers:	Protocol / IRB # 79045
Study First Received:	December 5, 2007
Results First Received:	November 6, 2009
Last Updated:	September 30, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Methamphetamine
Amphetamine
Modafinil
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012