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

This study has been completed.

Study NCT00654953 Information provided by University of Arkansas

First Received on April 4, 2008. Last Updated on March 28, 2011 History of Changes

Results First Received: March 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Cocaine Dependence Depressive Symptoms
Interventions:	Drug: sertraline Drug: Placebo Drug: gabapentin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 143 screened, 42 failed randomization/screening procedures and so were not randomized to receive study medication or placebo.

Reporting Groups

	Description
Placebo Group	Placebo capsules
Active Group: Sertraline Alone	sertraline (200 mg/day)
Active Group: Sertraline Plus Gabapentin	sertraline (200 mg/day) plus gabapentin (1,200 mg/day)

Participant Flow: Overall Study

	Placebo Group	Active Group: Sertraline Alone	Active Group: Sertraline Plus Gabapentin
STARTED	36	36	30
COMPLETED	6	8	8
NOT COMPLETED	30	28	22

Baseline Characteristics

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Reporting Groups

	Description
Placebo Group	Placebo capsules
Active Group: Sertraline Alone	sertraline (200 mg/day)
Active Group: Sertraline Plus Gabapentin	sertraline (200 mg/day) plus gabapentin (1,200 mg/day)

Baseline Measures

	Placebo Group	Active Group: Sertraline Alone	Active Group: Sertraline Plus Gabapentin	Total
Number of Participants [units: participants]	36	36	30	102
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	36	36	30	102
>=65 years	0	0	0	0
Age [units: years] Mean ± Standard Deviation	38.74 ± 6.32	39.78 ± 8.36	39.40 ± 7.81	39.31 ± 7.48
Gender [units: participants]
Female	12	10	6	28
Male	24	26	24	74
Region of Enrollment [units: participants]
United States	36	36	30	102

Outcome Measures

1. Primary:

Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites [ Time Frame: 70 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Alison Oliveto, Ph.D.
Organization: UAMS
phone: 501-526-8441
e-mail: olivetoalison@uams.edu

No publications provided

Responsible Party:	Alison Oliveto Beaudoin, UAMS
ClinicalTrials.gov Identifier:	NCT00654953 History of Changes
Other Study ID Numbers:	P50-DA018197, P50DA018197, P50-DA018197, DPMCDA
Study First Received:	April 4, 2008
Results First Received:	March 28, 2011
Last Updated:	March 28, 2011
Health Authority:	United States: Federal Government