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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to examine the ability of atomoxetine compared to placebo to increase time to relapse in methamphetamine dependent volunteers. Our hypothesis is that atomoxetine will increase time before (if) the participant relapses.
During the study participants will spend the initial 2-weeks of the study at an inpatient facility. This will help participants initiate withdrawal. During the following 8-weeks the participant will come in for 3-4 visits each week. Three of these visits will be with the research assistants and one visit will be with a therapist in order to work with the participant using a cognitive behavioral therapy approach. Therapy visits are typically scheduled on a day that the participant is coming for clinic anyways so the number of visits per week is typically 3. During the 10-week period the investigators will collect various measures, including vitals, cognitive assessments, mood assessments, urine drug screens, weekly use reports of methamphetamine, and any reports of symptoms or side effects. This will tell the investigators if atomoxetine is safe and if a participant lapsed or relapsed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Active Comparator | Group receiving atomoxetine |
|
| Placebo | Placebo Comparator | Group will receive placebo instead of atomoxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Time Till Relapse | The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse) | 57 days |
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Inclusion Criteria.
Exclusion Criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Alison Oliveto, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS, Psychiatric Research Institute, Center for Addiction Research | Little Rock | Arkansas | 72034 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine | Group receiving atomoxetine Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7) |
| FG001 | Placebo | Group will receive placebo instead of atomoxetine placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
those that received at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Atomoxetine | Group receiving atomoxetine Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Time Till Relapse | The number of days until a participant has a relapse, which will be measured by qualitative urine drug screens. To ensure a large enough sample, those who drop out prior to completing the residential stay will be included in this analysis (with minus days until relapse) | Only 4 of 13 finished the 2-week residential stay. Since subjects who drop out are deemed relapsed, all subjects receiving >/=1 dose of study med were included in the analyses. Those who dropped out before completing the residential stay were considered relapsed by the second day and the date of discharge was subtracted from this relapse date. | Posted | Median | Full Range | Days to Relapse | 57 days |
|
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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 | Atomoxetine | Group receiving atomoxetine Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anxiety | Psychiatric disorders | Systematic Assessment |
Recruitment and retention was much more difficult than anticipated. Because of, this too few (3 in ATM and 1 in PLA) were retained through the residential stay to determine efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Oliveto | UAMS | 501-526-8441 | olivetoalison@uams.edu |
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| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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|
| placebo | Drug | participants in this group will receive 1 dose of placebo daily for the entire 10-weeks. |
|
|
| Withdrawal by Subject |
|
| noncompliance with rules of residential |
|
| Placebo |
Group will receive placebo instead of atomoxetine placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Group will receive placebo instead of atomoxetine placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks. |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| EG001 | Placebo | Group will receive placebo instead of atomoxetine placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks. | 0 | 7 | 2 | 7 |
| sharp apin/tingling in limb | Nervous system disorders | Systematic Assessment |
|
| sleepiness/tiredness | General disorders | Systematic Assessment |
|
| night sweats | General disorders | Systematic Assessment |
|
| elevated BP (outside parameters) | Cardiac disorders | Systematic Assessment |
|
| elevated BP on 3 separate occasions | Cardiac disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
| insomnia | General disorders | Systematic Assessment |
|
| rapid heartbeat | Cardiac disorders | Systematic Assessment |
|
| irritability | Psychiatric disorders | Systematic Assessment |
|
| dry mouth | General disorders | Systematic Assessment |
|
| hot flash | General disorders | Systematic Assessment |
|
| chest pain | Cardiac disorders | Systematic Assessment |
|
| labored breathing | General disorders | Systematic Assessment |
|
| headache/pain | Nervous system disorders | Systematic Assessment |
|
| nausea/vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |