Methamphetamine DependencePhase 2NCT00569374
Safety and Tolerability of Modafinil for Methamphetamine Dependence
A Phase 2 study testing Modafinil in people with Methamphetamine Dependence, run by University of Arkansas at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
- Conditions
- Methamphetamine Dependence
- Being tested
- Modafinil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute.
Measured: Thrice weekly for 7 weeks
Systolic Blood Pressure
Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Measured: Thrice weekly for 7 weeks
Diastolic Blood Pressure
Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg.
Measured: Thrice weekly for 7 weeks
"Modafinil Side Effects Checklist"
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.
Measured: Weekly for 7 weeks
Anxiety as Measured by the Hamilton Anxiety Scale
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.
Measured: Thrice weekly for 7 weeks
Depression as Measured by the Hamilton Depression Scale
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.
Measured: Thrice weekly for 7 weeks
Secondary outcomes (1)
Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.
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.
Measured: Thrice weekly for the first three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Methamphetamine DependenceStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Investigators
- Dr. Janette McGaugh, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569374
- Sponsor's protocol ID
- Protocol / IRB # 79045
- Status last verified
- Sep 2010
- First submitted
- 5 Dec 2007
- Last updated
- 5 Oct 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Modafinil for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00569374
- Acronym / sponsor ID
- Protocol / IRB # 79045
- Conditions
- Methamphetamine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- First posted
- 7 Dec 2007 (estimated)
- Results
- Posted 22 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modafinilsubjects 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 | Drug | – |
Primary outcome
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.
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.
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.
"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.
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.
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.
1 secondary outcome
Methamphetamine Withdrawal as Measured Using the Amphetamine Withdrawal Questionaire.
Time frame: Thrice weekly for the first three weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Janette McGaugh, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Modafinil in people with Methamphetamine Dependence, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: Thrice weekly for 7 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2010.