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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA023650 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. The present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. During this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modafinil 0mg + Cocaine 0, 12, 25, 50 mg | Placebo Comparator | Participants were maintained on modafinil (0 mg/day) for 15 days, and underwent a dose response of cocaine. |
|
| Modafinil 200mg + Cocaine 0, 12, 25, 50 mg | Experimental | Participants were maintained on modafinil (200 mg/day) for 15 days, and underwent a dose response of cocaine. |
|
| Modafinil 400mg + Cocaine 0, 12, 25, 50 mg | Experimental | Participants were maintained on modafinil (400 mg/day) for 15 days, and underwent a dose response of cocaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modafinil 0 mg | Drug | Modafinil (0 mg/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Self-administration | The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition. | 48 days |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Quality Cluster | Visual analogue scale ratings on the 'Drug Quality' cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The "Drug Quality Cluster" consisted of three items:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Haney, Ph.D. | NYS Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Modafinil + Cocaine | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and underwent a dose response of smoked cocaine (0, 12, 25, and 50mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg).
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| ID | Title | Description |
|---|---|---|
| BG000 | Modafinil + Cocaine | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| 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 | Cocaine Self-administration | The number of purchased cocaine doses as a function of cocaine dose and modafinil maintenance condition. | Eight patients contributed to each condition, in a within-subjects manner. | Posted | Mean | Standard Error | Number of doses purchased | 48 days |
|
48 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 | Modafinil 0 mg + Cocaine (0, 12, 25, and 50mg) | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (0 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg). |
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This study is limited by the small, non-diverse sample.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Haney, Ph.D. | New York State Psychiatric Institute at Columbia University Medical Center | 646-774-6153 | meg.haney@nyspi.columbia.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 |
| D003042 | Cocaine |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Modafinil 200 mg |
| Drug |
Modafinil (200 mg/day) |
|
| Modafinil 400 mg | Drug | Modafinil (400 mg/day) |
|
| Cocaine 0 mg | Drug | Cocaine (0 mg/day) |
|
| Cocaine 12 mg | Drug | Cocaine (12 mg/day) |
|
| Cocaine 25 mg | Drug | Cocaine (25 mg/day) |
|
| Cocaine 50 mg | Drug | Cocaine (50 mg/day) |
|
| 48 days |
| Heart Rate | Values for heart rate as a function of cocaine dose and modafinil maintenance condition. | 48 days |
| rash while on placebo |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Modafinil 400mg + Cocaine 0mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG003 | Modafinil 0mg + Cocaine 12mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG004 | Modafinil 200mg + Cocaine 12mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG005 | Modafinil 400mg + Cocaine 12mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG006 | Modafinil 0mg + Cocaine 25mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG007 | Modafinil 200mg + Cocaine 25mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG008 | Modafinil 400mg + Cocaine 25mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG009 | Modafinil 0mg + Cocaine 50mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG010 | Modafinil 200mg + Cocaine 50mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
| OG011 | Modafinil 400mg + Cocaine 50mg | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (placebo, 200, and 400mg/day) and four doses of smoked cocaine (0, 12, 25, and 50mg). |
|
|
| Secondary | Drug Quality Cluster | Visual analogue scale ratings on the 'Drug Quality' cluster as a function of cocaine dose and modafinil maintenance condition. A cluster score was derived by taking the arithmetic average of the items in the cluster. Scores range from 0-100, with higher scores indicating greater agreement with the term. The "Drug Quality Cluster" consisted of three items:
| Eight subjects participants in each condition in a within-subjects fashion. | Posted | Mean | Standard Error | units on a scale | 48 days |
|
|
|
| Secondary | Heart Rate | Values for heart rate as a function of cocaine dose and modafinil maintenance condition. | Eight patients participated in each condition in a within-subjects fashion. | Posted | Mean | Standard Error | BPM | 48 days |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Modafinil 200 mg + Cocaine (0, 12, 25, and 50mg) | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (200 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg). | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Modafinil 400 mg + Cocaine (0, 12, 25, and 50mg) | During this within-subjects, alternating in-patient/outpatient 48-day study, participants were maintained on modafinil (400 mg/day) and a dose response of four doses of smoked cocaine (0, 12, 25, and 50mg). | 0 | 8 | 0 | 8 | 0 | 8 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |