Addiction
Conditions
Keywords
Abstinent cocaine users, cognitive testing
Brief summary
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.
Detailed description
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)
Interventions
DRUGAtomoxetine
Atomoxetine 40mg and 80mg compared to the sugar pill
DRUGSugar Pill
Sugar pill compared to Atomoxetine 40mg and 80mg.
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Male and females, between the ages of 21 and 50; * No current dependence or abuse of drugs of abuse or alcohol (except and tobacco); * No current medical problems and normal ECG; * For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.
Exclusion criteria
* Current major psychiatric illnesses including mood, psychotic, or anxiety disorders; * History of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study; * Known allergy to Atomoxetine; * Use of Monoamine Oxidase inhibitor within the last month (clinically Atomoxetine administration is contraindicated with or within 2 weeks of discontinuation of Monoamine oxidase inhibitor therapy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rapid Visual Information Processing | 2 years | 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. |
| Rapid Visual Information Processing: Mean Correct Response Latency | 2 years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Total Sample This is the summary of the total sample used in the crossover design. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | Total Sample |
|---|---|
| Age, Continuous | 41.21 years STANDARD_DEVIATION 7.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 39 | 0 / 39 |
| other Total, other adverse events | 1 / 39 | 1 / 39 | 1 / 39 |
| serious Total, serious adverse events | 0 / 39 | 0 / 39 | 0 / 39 |
Outcome results
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.
Time frame: 2 years
Population: Participants that completed any arm in the crossover are included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Atomoxetine 40 mg | Rapid Visual Information Processing | Descriminability | 0.88 Proportion of Participants | Standard Deviation 0.06 |
| Atomoxetine 40 mg | Rapid Visual Information Processing | Response Bias | 0.87 Proportion of Participants | Standard Deviation 0.14 |
| Atomoxetine 80 mg | Rapid Visual Information Processing | Descriminability | 0.89 Proportion of Participants | Standard Deviation 0.07 |
| Atomoxetine 80 mg | Rapid Visual Information Processing | Response Bias | 0.86 Proportion of Participants | Standard Deviation 0.16 |
| Sugar Pill 0mg | Rapid Visual Information Processing | Descriminability | 0.87 Proportion of Participants | Standard Deviation 0.05 |
| Sugar Pill 0mg | Rapid Visual Information Processing | Response Bias | 0.89 Proportion of Participants | Standard Deviation 0.22 |
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.
Time frame: 2 years
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Atomoxetine 40 mg | Rapid Visual Information Processing: Mean Correct Response Latency | 446.70 milliseconds | Standard Deviation 106.84 |
| Atomoxetine 80 mg | Rapid Visual Information Processing: Mean Correct Response Latency | 452.64 milliseconds | Standard Deviation 133.22 |
| Sugar Pill 0mg | Rapid Visual Information Processing: Mean Correct Response Latency | 464.44 milliseconds | Standard Deviation 113.07 |