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

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00654953

Purpose

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.

Condition	Intervention	Phase
Cocaine Dependence Depressive Symptoms	Drug: sertraline Drug: Placebo Drug: gabapentin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Sertraline Augmented With GABA Agents for Cocaine Dependence

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Cocaine hydrochloride Gabapentin Sertraline hydrochloride Sertraline

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Urine toxicology results for cocaine/metabolite or other illicit drugs [ Time Frame: thrice-weekly for 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

scores on Ham-D [ Time Frame: weekly for 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	105
Study Start Date:	January 2006
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo capsules	Drug: Placebo Placebo (cellulose or lactose) administered twice per day for 12 weeks.
2: Experimental sertraline (200 mg/day)	Drug: sertraline 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. Drug: Placebo Placebo (cellulose or lactose) administered twice per day for 12 weeks.
3: Experimental sertraline (200 mg/day) plus gabapentin (1,200 mg/day)	Drug: sertraline 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. Drug: gabapentin 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.

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. Compliance with study requirements during weeks 3-12 will be facilitated through the use of contingency management procedures (see below), whereby subjects are given monetary compensation for attendance and for returning blister packs. 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654953

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205 7911

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Alison Oliveto, PhD

University of Arkansas

More Information

No publications provided

Responsible Party:	UAMS ( Alison Oliveto Beaudoin )
Study ID Numbers:	P50-DA018197, P50-DA018197, DPMCDA
Study First Received:	April 4, 2008
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00654953 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

cocaine dependence
depressive symptoms
relapse
sertraline
gabapentin

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Gabapentin
Physiological Effects of Drugs
Psychotropic Drugs
Calcium Channel Blockers
Antiparkinson Agents
Disorders of Environmental Origin
Anesthetics
Excitatory Amino Acid Agents
Membrane Transport Modulators
Mental Disorders

Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Substance-Related Disorders
Sertraline
Analgesics
Cocaine
Antidepressive Agents
Excitatory Amino Acid Antagonists
Cocaine-Related Disorders
Tranquilizing Agents
Depression
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents

ClinicalTrials.gov processed this record on February 08, 2010