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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute. | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Janette McGaugh, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil | All participants were started on Modafinil titrated to 400mg in this open label trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil | All participants were started on Modafinil titrated to 400mg in this open label trial. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate | Heart rate as a safety measure was measured by thrice weekly measuring heart rate in beats per minute. | The data reported was obtained by computing the overall mean heart rate for each participant, then using these to compute the overall mean. | Posted | Sep 2009 | Mean | Standard Deviation | beats per minute | Thrice weekly for 7 weeks |
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These results were collected over a period of 1 year and 10 months. Five Adverse events occurred during the study, of which three were probably related to study participation.
Adverse events included one report each of tachycardia and dry mouth. The third occurred when a subject missed a dose on one day and took a double dose the next day. The subject experienced tachycardia, dry mouth, nervousness which resolved within one hour of modafinil ingestion.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modafinil | All participants were started on Modafinil titrated to 400mg in this open label trial. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | General disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Oliveto | University of Arkansas for Medical Sciences Center for Addiction Research | 501-526-8441 | olivetoalison@uams.edu |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Thrice weekly for 7 weeks |
| Thrice weekly for the first three weeks |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Systolic Blood Pressure | Systolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg. | The data reported was obtained by computing the overall mean systolic blood pressure for each participant, then using these to compute the overall mean. | Posted | Sep 2009 | Mean | Standard Deviation | mmHg | Thrice weekly for 7 weeks |
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| Primary | Diastolic Blood Pressure | Diastolic blood pressure as a safety measure was measured by thrice weekly measuring blood pressure in mmHg. | The data reported was obtained by computing the overall mean diastolic blood pressure for each participant, then using these to compute the overall mean. | Posted | Sep 2009 | Mean | Standard Deviation | mmHg | Thrice weekly for 7 weeks |
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| Primary | "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. | The data reported was obtainined by computing the overall mean numberical score on the Modafinil Side Effects Checklist for each participant, then using these to compute the overall mean. The checklist is a 10 item scale with each item scoring between 0 (none) to 4 (worst). The potential scores range from 0 (least) to 40 (worst). | Posted | Sep 2009 | Mean | Standard Deviation | units on a scale | Weekly for 7 weeks |
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| Primary | 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. | The data reported was obtained by computing the overall mean score on the Hamilton Anxiety Scale for each participant, then using these to compute the overall mean. The scale is a 14 item instrument with each item scoring a potential range of 0 (none) to 4 (worst). The potential total scores range form 0 (least) to 56 (worst). | Posted | Sep 2009 | Mean | Standard Deviation | units on a scale | Thrice weekly for 7 weeks |
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| Primary | 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. | The data reported was obtained by computing the overall mean score on the Hamilton Depression Scale for each participant, then using these to compute the overall mean. It is a 22 item scale of which 13 items have a score of 0 (none) to 4 (worst) and 9 have a score of 0 (none) to 2 (worst). The total score ranges from 0 (least) to 70 (worst). | Posted | Sep 2009 | Mean | Standard Deviation | units on a scale | Thrice weekly for 7 weeks |
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| Secondary | 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. | The data reported was obtained by computing the overall mean numerical score on the Amphetamine Withdrawal Questionaire for each participant, then using these to compute the overall mean. The scale consists of 13 items ranging from 0 (none) to 4 (worst). The total score ranges from 0 (least) to 52 (worst). | Posted | Sep 2009 | Mean | Standard Deviation | units on a scale | Thrice weekly for the first three weeks |
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| 0 |
| 8 |
| 3 |
| 8 |
| Dry mouth | General disorders |
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| Tachycardia, dry mouth, nervousness after taking extra dose | General disorders |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |