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The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.
This will be a double-blind, placebo-controlled, crossover study, with cocaine use (cocaine users vs. healthy controls) and NET AAGG4 status (L4/ L4 vs. L4/S4 or S4/ S4 genotype) as the between-subject factors. Similar to previous studies, we propose to compare individuals with two copies of the L4 allele to participants with at least one S4 allele because only less than two percent of the general population is homozygous for the S4 allele. Forty cocaine users and 40 healthy controls will participate in 3 test sessions, where they will be assigned to 40 mg atomoxetine, 80 mg atomoxetine, or placebo. Outcome measures will include physiological, subjective, and cognitive performance measures.
To date this study has 35 completers and currently in data analysis. (January 2016)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atomoxetine | Active Comparator | Atomoxetine compared to the sugar pill |
|
| Sugar Pill | Placebo Comparator | Sugar pill compared to atomoxetine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atomoxetine | Drug | Atomoxetine 40mg and 80mg compared to the sugar pill |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rapid Visual Information Processing | Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets. | 2 years |
| Rapid Visual Information Processing: Mean Correct Response Latency | Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Sofuoglu, M.D., Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Veterans Affairs | West Haven | Connecticut | 06516 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants | Participants were randomly assigned to one of 3 possible groups over a 3 day assessment period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The total number of people enrolled in the study before randomization to crossover assignment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Sample | This is the summary of the total sample used in the crossover design. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rapid Visual Information Processing | Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets. | Participants that completed any arm in the crossover are included in the analysis. | Posted | Mean | Standard Deviation | Proportion of Participants | 2 years |
|
Adverse events were collected once for each of the three visits on all enrolled subjects.
The assessment of adverse events utilized the Brief Symptom Inventory (BSI), an instrument that consists of 77 items.
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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 40 mg | Atomoxetine 40 mg dose | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mehmet Sofuoglu, Professor of Psychiatry; Director of VA New England Mental Illness Research, Ed | Yale University | (203) 937-4809 | mehmet.sofuoglu@yale.edu |
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| ID | Term |
|---|---|
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
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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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| Sugar Pill | Drug | Sugar pill compared to Atomoxetine 40mg and 80mg. |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Atomoxetine 80 mg |
Atomoxetine 80 mg dose |
| OG002 | Sugar Pill 0mg | Sugar pill 0mg dose |
|
|
| Primary | Rapid Visual Information Processing: Mean Correct Response Latency | Cognitive Test to determine the speed of Visual information. The CANTAB Rapid Visual Information Processing test (RVP) is a measure of sustained attention with a small working memory component (Sahakian and Owen, 1992). Digits are rapidly (100/minute) and pseudo-randomly presented for 7 minutes. Subjects are instructed to press when the third digit of a target sequence (e.g. 3-5-7) is displayed. Primary outcomes are indices of target discriminability (A') and response bias (B") and response latency to targets. | Participants that completed any arm in the crossover are included in the analysis, participants with valid observations at both indices are included in the calculation. | Posted | Mean | Standard Deviation | milliseconds | 2 years |
|
|
|
| 39 |
| 0 |
| 39 |
| 1 |
| 39 |
| EG001 | Atomoxetine 80 mg | Atomoxetine 80 mg dose | 0 | 39 | 0 | 39 | 1 | 39 |
| EG002 | Sugar Pill 0 mg | Sugar pill 0 mg dose | 0 | 39 | 0 | 39 | 1 | 39 |
| headache | General disorders | Systematic Assessment |
|
| other | General disorders | Systematic Assessment | non-life threatening, non-specific event |
|
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