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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA011744 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Subjects participating in this protocol will participate in three phases: 1) pre-admission, 2) inpatient admission, and 3) follow-up. Pre-admission involves screening (detailed in inclusion/exclusion criteria section) and one week of outpatient sleep and activity monitoring. Inpatient admission is 16 consecutive nights on the Clinical Neuroscience Research Unit and involves subjective and objective tests of sleep, sleepiness, attention, and learning. During inpatient admission subjects will take modafinil or placebo. For follow-up, subjects will return to the CNRU for one night and again participate in objective tests of sleep, sleepiness, attention, and learning. We hypothesize that modafinil will decrease subject and objective measures of sleepiness and will promote attention and learning in cocaine dependent persons.
A relatively new treatment for the excessive daytime sleepiness (EDS) associated with inadequate sleep is the drug modafinil. Modafinil decreases subjective reports and objective measures of daytime sleepiness under conditions of sleep restriction, while enhancing cognitive performance. At the same time, sleep quality does not appear to be affected significantly. Interestingly, recent clinical trials in cocaine-dependent populations suggest that modafinil reduces the relapse to cocaine use, by unknown mechanisms.
We propose to employ both subjective and objective measures of nocturnal sleep and daytime sleepiness, as well as measures of general cognitive performance and sleep-dependent memory consolidation, to explore potential mechanistic relationships between cocaine abstinence, EDS, and modafinil's efficacy in preventing cocaine relapse.
The following specific aims are proposed:
Specific Aim 1: To establish whether objective measures of poor nocturnal sleep (e.g., reduced total sleep time and sleep efficiency) that progressively characterize periods of sustained cocaine abstinence are also associated with objective evidence of excessive daytime sleepiness (EDS).
Specific Aim 2: To establish the ability of modafinil to reverse the excessive daytime sleepiness (EDS) and deficits in cognitive performance that characterize cocaine abstinence.
Specific Aim 3: To conduct a pilot study to determine whether the observed abnormalities in objective sleep, EDS, and/or cognitive function predict relapse to cocaine use and/or whether successful abstinence from cocaine is associated with normalization of the same.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Modafinil 400mg orally everyday for 16 days |
|
| II | Placebo Comparator | Placebo orally everyday for 16 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil | Drug | Modafinil 400mg orally every day for 16 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time (Minutes) | Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | After 1 Week |
| Total Sleep Time (Minutes) | Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | After 2 Weeks |
| Total Sleep Time (Minutes) | Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | After 3 Weeks |
| Time Spent in Sleep Stage 3 (Minutes) | Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | After 1 Week |
| Time Spent in Sleep Stage 3 (Minutes) | Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Sleep Quality on Visual Analog Scale (Millimeters) | Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter T Morgan, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
44 participants with self-identified cocaine problems responded to newspaper advertisements and passed initial telephone screening. Of those who passed the telephone screening, 29 were found to be qualified for participation after in-person screening. 21 participants entered the study and were subsequently randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil 400mg | Modafinil 400mg orally everyday for 16 days |
| FG001 | Placebo | Placebo orally everyday for 16 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil (400mg) | Participants received single oral dose of modafinil (400mg) every morning for 16 days |
| BG001 | Placebo | Participants received a single oral placebo every morning for 16 days |
| 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 | Total Sleep Time (Minutes) | Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | The number of participants who completed the study were analyzed | Posted | Mean | Standard Deviation | Minutes | After 1 Week |
|
Throughout the length of the study (approximately 2 1/2 years)
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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 (400mg) | Participants received single oral dose of modafinil (400mg) every morning for 16 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back/Neck Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Morgan, MD, PhD | Yale University School of Medicine | 203-974-7515 | Peter.Morgan@yale.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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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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| Placebo | Drug | Placebo orally everyday for 16 days |
|
| After 2 Weeks |
| Time Spent in Sleep Stage 3 (Minutes) | Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | After 3 Weeks |
| After 1 Week |
| Overall Sleep Quality on Visual Analog Scale (Millimeters) | Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. | After 2 Weeks |
| Overall Sleep Quality on Visual Analog Scale (Millimeters) | Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. | After 3 Weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Participants received a single oral placebo every morning for 16 days
|
|
| Secondary | Overall Sleep Quality on Visual Analog Scale (Millimeters) | Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. | The number of participants who completed the study were analyzed. | Posted | Mean | Standard Deviation | Millimeters | After 1 Week |
|
|
|
| Primary | Total Sleep Time (Minutes) | Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | The number of participants who completed the study were analyzed | Posted | Mean | Standard Deviation | Minutes | After 2 Weeks |
|
|
|
| Primary | Total Sleep Time (Minutes) | Total sleep time was defined as the time from sleep onset until final awakening minus the time awake after sleep onset. Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | The number of participants who completed the study were analyzed | Posted | Mean | Standard Deviation | Minutes | After 3 Weeks |
|
|
|
| Primary | Time Spent in Sleep Stage 3 (Minutes) | Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | The number of participants who completed the study were analyzed | Posted | Mean | Standard Deviation | Minutes | After 1 Week |
|
|
|
| Primary | Time Spent in Sleep Stage 3 (Minutes) | Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | The number of participants who completed the study were analyzed | Posted | Mean | Standard Deviation | Minutes | After 2 Weeks |
|
|
|
| Primary | Time Spent in Sleep Stage 3 (Minutes) | Experimental polysomnographic sleep measurement was performed on the following three study night blocks: 1 to 3, 7 to 9, and 14 to 16. Data from each three-night block were averaged and reported as weeks 1, 2, and 3 respectively. | The number of participants who completed the study were analyzed | Posted | Mean | Standard Deviation | Minutes | After 3 Weeks |
|
|
|
| Secondary | Overall Sleep Quality on Visual Analog Scale (Millimeters) | Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. | The number of participants who completed the study were analyzed. | Posted | Mean | Standard Deviation | Millimeters | After 2 Weeks |
|
|
|
| Secondary | Overall Sleep Quality on Visual Analog Scale (Millimeters) | Upon awakening, participants rated their "overall quality of sleep". Ratings were indicated by the participants marking an "X" on 100 mm lines (ie "worse," "best"). The placement of the "X" was measured, using a ruler, to the nearest millimeter and thus ranged from 0 mm to 100 mm. Lower scores correspond to a worse quality of sleep and higher scores correspond to a better sleep quality. Subjective measures from days 1 to 3, 7 to 9, and 14 to 16 were averaged to correspond to weeks 1, 2, and 3. | The number of participants who completed the study were analyzed. | Posted | Mean | Standard Deviation | Millimeters | After 3 Weeks |
|
|
|
| 0 |
| 10 |
| 6 |
| 10 |
| EG001 | Placebo | Participants received a single oral placebo every morning for 16 days | 0 | 10 | 3 | 10 |
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Heart Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |