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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA022191 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| National Institute on Drug Abuse (NIDA) | NIH |
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This placebo-controlled, double-blind, randomized pilot clinical trial will evaluate atomoxetine (Strattera®) for the treatment of cocaine dependence. Cocaine-dependent individuals, who are healthy and are seeking treatment for their substance abuse, will be randomized to receive either atomoxetine (n=25) or a matched-placebo (n=25) during a trial lasting 12 weeks; there will be a double-blind, ascending dose lead-in order to achieve maintenance on the assigned active dose safely. Contingency management procedures will be used to reinforce attendance and compliance with study procedures. Primary outcome measures will include urinalysis data assessing cocaine use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Atomoxetine |
|
| 2 | Placebo Comparator | Matched Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| atomoxetine | Drug | Once daily oral dosing |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| % Urine Samples Negative for Cocaine | Total % urine samples negative for benzoylecgonine over the 12-week trial | Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Trial retention- those who complete the 12 week dosing period | 12-weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharon L Walsh, Ph.D. | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Straus Research Building | Lexington | Kentucky | 40502 | United States |
Exclusions included dependence on any drug requiring detoxification, other Axis I disorders, medical problems, pregnant or lactating females, Cytochrome P450 2D6 inhibitors/inducers, monoamine oxidase inhibitors or selective serotonin reuptake inhibitors. Enrollment in other drug treatment programs urine samples required for parole/probation.
Adult volunteers ages 18-60 reporting cocaine use in the preceding 30 days who met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) criteria for and were seeking treatment for cocaine dependence were recruited through advertisements and word-of-mouth to a research clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atomoxetine (80 mg/Day) | Active drug atomoxetine : Once daily oral dosing |
| FG001 | Matched Placebo | Matched Placebo placebo : Once daily oral dosing - matched placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matched placebo |
| BG001 | Atomoxetine | Atomoxetine (80 mg/day) |
| BG002 |
| 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 | % Urine Samples Negative for Cocaine | Total % urine samples negative for benzoylecgonine over the 12-week trial | Intent-to-treat analysis included all subjects with missing urine sample counted as positive. | Posted | Number | percentage of positive urine samples | Urines were collected 3 times per week (e.g., Monday, Wednesday and Friday) for 12 weeks | Urine samples | Urine samples |
|
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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 (80 mg/Day) | Active drug atomoxetine : Once daily oral dosing |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sharon Walsh | University of Kentucky | 859-257-2684 | sharon.walsh@uky.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069445 | Atomoxetine Hydrochloride |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| placebo | Drug | Once daily oral dosing - matched placebo |
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| Total |
Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Urine samples |
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| Secondary | Retention | Trial retention- those who complete the 12 week dosing period | those completing the 12-week study after randomization | Posted | Mean | Standard Error | days | 12-weeks |
|
|
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| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Matched Placebo | Matched Placebo placebo : Once daily oral dosing - matched placebo | 0 | 25 | 0 | 25 |
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