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Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users

NCT ID: NCT00183768

Last Updated: 2013-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2003-02-28

Brief Summary

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This study will evaluate the effectiveness of combining cognitive behavioral therapy (CBT) and antidepressants in reducing HIV risk behavior and drug relapse rates in depressed intravenous drug users.

Detailed Description

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Depression is common among injection drug users (IDUs); it is estimated that up to 50% of IDUs meet the diagnostic criteria for major depressive disorder, a severe form of depression. The combination of drug abuse and depression increases the likelihood of engaging in HIV high-risk behaviors such as unprotected sex and the use of unhygienic needles to inject drugs. Research has shown that IDUs who receive treatment for depression have lower rates of drug relapse and are less likely to engage in high-risk sexual behavior compared to IDUs who have not received treatment for depression. Combination treatment, which includes cognitive behavioral therapy (CBT) and antidepressant medication, has been shown to be the most effective treatment for depression. This study will evaluate the effectiveness of combination treatment in reducing HIV risk behaviors and drug relapse rates in cocaine or opiate addicted IDUs with a diagnosis of depression.

In this 9-month study, participants will be randomly assigned to either a combination treatment group or an assessment only group that will receive no treatment. Participants assigned to combination treatment will receive the antidepressant Celexa, and will attend 8 CBT sessions and 7 psychopharmacology sessions. Each CBT session will last about 60 minutes and each psychopharmacology session will last about 15 minutes. If a participant does not respond well to Celexa, Wellbutrin or Effexor may be taken instead. Participants in both groups will attend 4 study visits during which they will complete standardized psychological questionnaires and interviews to assess depression levels, drug use, and high-risk sexual behaviors. Blood will be drawn at baseline and Month 9 for HIV testing.

Conditions

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HIV Infections Depression Substance-Related Disorders

Keywords

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Cognitive Behavioral Treatment For Depression Antidepressant Psychopharmacology HIV Risk Behavior Injection Drug Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

Psychopharmacology

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meets DSM-IV criteria for major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia
* Score of greater than 14 on the Hamilton Depression Rating Scale
* Involved in HIV risk behaviors
* Current opiate or cocaine use
* Basic proficiency in English

Exclusion Criteria

* Current suicidal risk or ideation
* Current psychotic symptoms
* Simultaneous medical disorder that might make psychopharmacological treatment medically inadvisable
* History of bipolar disorder, schizophrenia, schizo-affective disorder, schizophreniform disorder, or paranoid disorder
* Currently taking other medications for depression
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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RI Hospital

Principal Investigators

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Michael Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Penelope Dennehy, MD

Role: STUDY_DIRECTOR

Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Stein MD, Herman DS, Solomon DA, Anthony JL, Anderson BJ, Ramsey SE, Miller IW. Adherence to treatment of depression in active injection drug users: the minerva study. J Subst Abuse Treat. 2004 Mar;26(2):87-93. doi: 10.1016/S0740-5472(03)00160-0.

Reference Type RESULT
PMID: 15050085 (View on PubMed)

Stein MD, Solomon DA, Herman DS, Anthony JL, Ramsey SE, Anderson BJ, Miller IW. Pharmacotherapy plus psychotherapy for treatment of depression in active injection drug users. Arch Gen Psychiatry. 2004 Feb;61(2):152-9. doi: 10.1001/archpsyc.61.2.152.

Reference Type RESULT
PMID: 14757591 (View on PubMed)

Stein MD, Solomon DA, Herman DS, Anderson BJ, Miller I. Depression severity and drug injection HIV risk behaviors. Am J Psychiatry. 2003 Sep;160(9):1659-62. doi: 10.1176/appi.ajp.160.9.1659.

Reference Type RESULT
PMID: 12944342 (View on PubMed)

Other Identifiers

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R01MH061141

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR AZ-M

Identifier Type: -

Identifier Source: secondary_id

R01MH061141

Identifier Type: NIH

Identifier Source: org_study_id

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