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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA018197 | U.S. NIH Grant/Contract | View source | |
| DPMCDA |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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To examine the clinical efficacy of sertraline (200 mg/day) alone or sertraline in combination with gabapentin. The purpose of this study is to examine whether the antidepressant sertraline alone or combined with gabapentin delays time to relapse relative to placebo in recently abstinent cocaine-dependent volunteers who are also depressed. In addition, whether depressive symptoms or genetic factors influence treatment response to the study medications will be examined. Our hypothesis is that those on combined sertraline-gabapentin will show a longer period of abstinence than those on sertraline alone or placebo.
Subjects enrolled in this 12-wk, double blind, randomized, placebo-controlled, clinical trial are admitted to a residential facility in North Little Rock (RCA-NLR) and randomized by depressive symptom severity to receive one of the following: sertraline alone (200 mg/day), sertraline (200 mg/day) plus gabapentin (1200 mg/day), or placebo. Subjects are expected to participate in the Substance Abuse Day Treatment Program while residing on the RCA-NLR and being inducted onto the maintenance dose of study medication (weeks 1-2). When participants transfer to the Outpatient Treatment Research Unit (TRU) at the start of their third week, they will continue to receive study medications or placebo (weeks 3-12) and they will be expected to participate in weekly individual cognitive behavioral therapy. Supervised urines and vital signs will be obtained thrice weekly; self-reported adverse effects, mood and drug use self-reports will be obtained once weekly. At the end of 12 weeks, participants will be tapered off the study medication over a five-day period, discharged from the study, and referred to an appropriate treatment or treatment/research program in the community if they are interested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo capsules |
|
| 2 | Experimental | sertraline (200 mg/day) |
|
| 3 | Experimental | sertraline (200 mg/day) plus gabapentin (1,200 mg/day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sertraline | Drug | Sertraline hydrochloride (200 mg/day) will be administered once daily. While subjects are at RCA-NLR they initially receive 50 mg/day of sertraline. This dose is gradually increased over a 3-week period until subjects receive 200 mg. When subjects are transferred to the outpatient program, they will be administered capsules once weekly, with take-home doses given in blister packs to take once a day for the rest of the week. |
| Measure | Description | Time Frame |
|---|---|---|
| Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites | Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine. | 70 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Oliveto, PhD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 7911 | United States |
Of the 143 screened, 42 failed randomization/screening procedures and so were not randomized to receive study medication or placebo.
143 cocaine-using volunteers gave informed consent between 12/15/2005 and 4/8/2009. Consenting occurred at either the UAMS substance abuse treatment clinic, treatment research unit or center for addiction research at the UAMS Psychiatric Research Institute. Of these, 105 eligible participants were enrolled into the study proper.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | Placebo capsules |
| FG001 | Active Group: Sertraline Alone | sertraline (200 mg/day) |
| FG002 | Active Group: Sertraline Plus Gabapentin | sertraline (200 mg/day) plus gabapentin (1,200 mg/day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group | Placebo capsules |
| BG001 | Active Group: Sertraline Alone | sertraline (200 mg/day) |
| 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 | Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites | Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine. | Participants who completed the two-week residential stay and had 2 urine samples consecutively positive for cocaine were included in the analysis. | Posted | Mar 2011 | Mean | Standard Deviation | Days to relapse (two consec coc+ urines) | 70 days | urine samples | Participants |
|
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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 | Placebo Group | Placebo capsules |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic Reaction | Immune system disorders | Systematic Assessment | Allergic reaction to study medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sexual dysfunction | Reproductive system and breast disorders | Non-systematic Assessment | erectile dysfunction/impotence/inability or delayed orgasm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alison Oliveto, Ph.D. | UAMS | 501-526-8441 | olivetoalison@uams.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D003863 | Depression |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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| ID | Term |
|---|---|
| D020280 | Sertraline |
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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|
| Placebo | Drug | Placebo (cellulose or lactose) administered twice per day for 12 weeks. |
|
| gabapentin | Drug | Gabapentin (Neurontin; Parke-Davis; 1200 mg/day) will be administered twice daily. Initially, patients will receive 200 mg twice daily on days 1-5, 400 mg twice daily on days 6-10, then 600 mg twice daily on days 11 on. Subjects are then maintained on this dose for the duration of the trial, unless side-effects are too severe, in which case the dose of gabapentin is decreased to no less 800 mg/day. If symptoms persist, subjects' participation would then be terminated. |
|
| BG002 |
| Active Group: Sertraline Plus Gabapentin |
sertraline (200 mg/day) plus gabapentin (1,200 mg/day) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 36 |
| 7 |
| 36 |
| EG001 | Active Group: Sertraline Alone | sertraline (200 mg/day) | 0 | 36 | 17 | 36 |
| EG002 | Active Group: Sertraline Plus Gabapentin | sertraline (200 mg/day) plus gabapentin (1,200 mg/day) | 1 | 30 | 14 | 30 |
|
|
| Chest Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Chest pain in which cardiac involvement was ruled out. |
|
| dizziness | Cardiac disorders | Non-systematic Assessment | self-reported dizziness |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| Nausea and/or Emesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| High Blood Pressure | Cardiac disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| toothache and/or tooth abscess | Musculoskeletal and connective tissue disorders |
|
| Skin Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Anxiety | Nervous system disorders | Non-systematic Assessment |
|
| Sore Throat | Infections and infestations | Non-systematic Assessment |
|
| Yawning | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |