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| ID | Type | Description | Link |
|---|---|---|---|
| 1U01DA033310-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The proposed protocol is a multi-site double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (MAS-ER) and topiramate in the treatment of cocaine dependence. 198 patients will be enrolled and 176 patients randomized in a 14-week trial. The proportion of participants achieving sustained cocaine abstinence for three consecutive weeks at the end of the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.
The investigators hypothesize that the combination of an agent that increased baseline dopamine signaling (amphetamine) with one that reduced cocaine-induced dopamine release (topiramate) will improve dopamine regulation and be associated with improved cocaine use outcomes. 99 subjects at each of the two sites whom meet criteria for cocaine dependence, and all other study inclusion and exclusion criteria will be assigned to the 14-week double-blind, placebo-controlled treatment trial. Subjects will be randomized to receive either placebo or MAS-ER and topiramate. This proposal will test the hypothesis that MAS-ER and topiramate will promote cocaine abstinence. Participants who are randomized to the combination medication arm will have their dose titrated to 60 mg MAS-ER daily (over 2 weeks) and 200 mg topiramate a day (over 6 weeks) and maintained on this dose through week 13 of the trial. During week 14, participants will be tapered off both medications. All participants will receive a supportive behavioral treatment that emphasizes study procedure adherence. Starting in week one, all patients will receive incentives for compliance with study procedures on an escalating reinforcement schedule similar to that developed previously and not contingent on urine results. The purpose of the lead-out is to blind patients to the exact point of medication discontinuation and to provide naturalistic data on the effects of medication discontinuation. Moreover, a 3 month follow-up will be conducted to determine what happens to cocaine use after treatment discontinuation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adderall-ER and Topiramate | Experimental | Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study. |
|
| Placebo | Placebo Comparator | Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adderall-ER | Drug | MAS-ER 60mg/day |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Three Weeks of Cocaine Abstinence at End of Study | The number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week. | assessed during 14 weeks of trial, presented for last 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Any Three Consecutive Weeks of Abstinence During Study | The proportion of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at any time during the 14 week trial. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB)and corroborated by the urine toxicology samples collected 3 times per week. | 14 weeks of study or length of study participation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frances Levin, M.D. | Columbia University | Principal Investigator |
| Kyle Kampman, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| STARS | New York | New York | 10032 | United States | ||
| University of Pennsylvania |
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| Label | URL |
|---|---|
| stars website | View source |
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169 individuals enrolled in the trial and entered a 1 week placebo lead-in. 42 participants were not randomized due to several reasons including 16 being considered to be placebo-responders and 18 being lost to follow-up. 127 participants were then randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adderall-ER and Topiramate | Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study. Adderall-ER: MAS-ER 60mg/day Topiramate: Topiramate 100 mg bid. |
| FG001 | Placebo | Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm. Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adderall-ER and Topiramate | Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study. Adderall-ER: MAS-ER 60mg/day Topiramate: Topiramate 100 mg bid. |
| 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 | Three Weeks of Cocaine Abstinence at End of Study | The number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week. | Posted | Count of Participants | Participants | assessed during 14 weeks of trial, presented for last 3 weeks |
|
collected during 14 weeks of trial or length of participation
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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 | Adderall-ER and Topiramate | Adderall-ER will be taken once per day in the morning or early afternoon since it may be activating. The dose is titrated to 60 mg per day or the maximum tolerated dose over two weeks and maintained for the duration of the study. Topiramate will be taken twice per day in the morning and the evening and titrated to 200mg/day or the maximum tolerated dose over the course of 6 weeks and maintained for the duration of the study. Adderall-ER: MAS-ER 60mg/day Topiramate: Topiramate 100 mg bid. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | One patient was hospitalized for 48 hours due to an exacerbation of preexisting asthma. Upon receiving treatment, the symptoms subsided. Hospitalization was not considered related to study procedures. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| headache | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frances R. Levin, M.D. | NYSPI | 646-774-6137 | Frances.levin@nyspi.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 5, 2017 | Aug 16, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 1, 2018 | Sep 13, 2018 | SAP_001.pdf |
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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 |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Topiramate | Drug | Topiramate 100 mg bid. |
|
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| Placebo | Other | Placebo |
|
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| BG001 | Placebo | Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm. Placebo: Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| education | Count of Participants | Participants |
|
| employment status | Count of Participants | Participants |
|
| Currently married | Count of Participants | Participants |
|
| OG001 | Placebo | Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm. Placebo: Placebo |
|
|
| Secondary | Any Three Consecutive Weeks of Abstinence During Study | The proportion of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at any time during the 14 week trial. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB)and corroborated by the urine toxicology samples collected 3 times per week. | Posted | Count of Participants | Participants | 14 weeks of study or length of study participation |
|
|
|
| 0 |
| 64 |
| 2 |
| 64 |
| 52 |
| 64 |
| EG001 | Placebo | Placebo will be packaged in matching gelatin capsules similar to the pills in the active arm. Placebo will be taken as frequently and for the same duration as those taken in the active arm. Placebo: Placebo | 0 | 63 | 2 | 63 | 44 | 63 |
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| inpatient rehabilitation | General disorders | Systematic Assessment | patient voluntarily entered an inpatient rehabilitation program. |
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| leg swelling/pain | General disorders | Systematic Assessment | One participant presented to the ER with pain and swelling in both legs. He was admitted for 48 hours for observation in the hospital and treated with antibiotics. |
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| insomnia | General disorders | Systematic Assessment |
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| URI | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| increased blood pressure | Cardiac disorders | Systematic Assessment |
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| anorexia | Gastrointestinal disorders | Systematic Assessment |
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| dry mouth | General disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
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| GI upset | Gastrointestinal disorders | Systematic Assessment |
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| muscle aches | General disorders | Systematic Assessment |
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| paresthesia | General disorders | Systematic Assessment |
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| anxiety | General disorders | Systematic Assessment |
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| dizziness | General disorders | Systematic Assessment |
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| drowsiness | General disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| increased heart rate | Cardiac disorders | Systematic Assessment |
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| Carbohydrates |
| D007661 | Ketoses |