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Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

Primary Purpose

Cocaine Dependence, Depressive Symptoms

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

sertraline

Placebo

gabapentin

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring cocaine dependence, depressive symptoms, relapse, sertraline, gabapentin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18-65 years old
not currently enrolled in a treatment program
subjects must have a history of cocaine use, with street cocaine use by history being a minimum of 1 gram during the preceding 3 months
subjects must meet DSM-IV criteria for cocaine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID and SCID-SAC)
subjects must have laboratory confirmation of recent cocaine use (positive urine for cocaine or benzoylecgonine) during the month prior to study entry
subjects must score at least 15 on the Hamilton Depression Scale
women of childbearing age must have a negative pregnancy test to enroll in this study and must agree to monthly pregnancy testing

Exclusion Criteria:

current diagnosis of other drug or alcohol physical dependence (other than cocaine or tobacco)
ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
history of schizophrenia, or bipolar type I disorder
present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested
medical contraindication to receiving study medications (e.g., for sertraline, use of monoamine oxidase inhibitor within last two weeks; significant history of seizures; significant history of head trauma or serious neurological disorders)
current suicidality or psychosis
Liver function tests (i.e., liver enzymes) greater than three times normal levels
pregnancy

Sites / Locations

University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Placebo capsules

sertraline (200 mg/day)

sertraline (200 mg/day) plus gabapentin (1,200 mg/day)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00654953

First Posted

April 4, 2008

Last Updated

March 28, 2011

Sponsor

University of Arkansas

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00654953

Brief Title

Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

Official Title

Sertraline Augmented With GABA Agents for Cocaine Dependence

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Arkansas

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cocaine Dependence, Depressive Symptoms

Keywords

cocaine dependence, depressive symptoms, relapse, sertraline, gabapentin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo capsules

Arm Title

Arm Type

Experimental

Arm Description

sertraline (200 mg/day)

Arm Title

Arm Type

Experimental

Arm Description

sertraline (200 mg/day) plus gabapentin (1,200 mg/day)

Intervention Type

Drug

Intervention Name(s)

sertraline

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (cellulose or lactose) administered twice per day for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

gabapentin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites

Description

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.

Time Frame

70 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-65 years old not currently enrolled in a treatment program subjects must have a history of cocaine use, with street cocaine use by history being a minimum of 1 gram during the preceding 3 months subjects must meet DSM-IV criteria for cocaine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID and SCID-SAC) subjects must have laboratory confirmation of recent cocaine use (positive urine for cocaine or benzoylecgonine) during the month prior to study entry subjects must score at least 15 on the Hamilton Depression Scale women of childbearing age must have a negative pregnancy test to enroll in this study and must agree to monthly pregnancy testing Exclusion Criteria: current diagnosis of other drug or alcohol physical dependence (other than cocaine or tobacco) ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder) history of schizophrenia, or bipolar type I disorder present or recent use of over-the-counter or prescription psychoactive drug or drug(s) that would be expected to have major interaction with drug to be tested medical contraindication to receiving study medications (e.g., for sertraline, use of monoamine oxidase inhibitor within last two weeks; significant history of seizures; significant history of head trauma or serious neurological disorders) current suicidality or psychosis Liver function tests (i.e., liver enzymes) greater than three times normal levels pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison Oliveto, PhD

Organizational Affiliation

University of Arkansas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205 7911

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

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