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Substance Dependent Teens - Impact of Treating Depression Study 1 - 1

Primary Purpose

Alcohol-Related Disorders, Marijuana Abuse, Substance-Related Disorders

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Fluoxetine + outpatient cognitive behavioral therapy

fluoxetine

placebo + CBT

About this trial

This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring alcohol dependence, marijuana dependence

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must have DSM IV non bipolar Major Depressive disorder (by clinical interview), DSM IV Conduct Disorder, and Non-Tobacco Substance Disorder. Exclusion Criteria: History of or current psychosis, history of psychotic depression, bipolar disorder I or II, family history of first degree relative with bipolar I, lifetime history of non-substance induced Mania/Hypomania Unstable chronic or serious medical illness Currently pregnant Take psychotrophic medication, past 2 months: medication or treatment for depression, clinically significant laboratory abnormality

Sites / Locations

University of Colorado Denver
1611 South Federal Blvd.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

fluoxetine + CBT

placebo + CBT

Outcomes

Primary Outcome Measures

To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems.

Secondary Outcome Measures

To determine if the treatment of depression with fluoxetine + CBT, in depressed adolescents with SUD and CD will be more effective than placebo + CBT in reducing substance use and improving conduct symptoms.

Full Information

NCT ID

NCT00061113

First Posted

May 21, 2003

Last Updated

January 11, 2017

Sponsor

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT00061113

Brief Title

Substance Dependent Teens - Impact of Treating Depression Study 1 - 1

Official Title

Substance Dependent Teens - Impact of Treating Depression Study 1

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

February 2001 (undefined)

Primary Completion Date

August 2006 (Actual)

Study Completion Date

August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the impact of treating depression on substance dependent teens.

Detailed Description

The primary study aim is to determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems. The current community standard of care often withholds pharmacotherapy for depression in substance abusing adolescents, since it is often assumed that their depressions may remit with SUD treatment alone. However, this is an untested hypothesis in adolescents and one that we propose to test in the current study.

6. Conditions and Keywords

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

Alcohol-Related Disorders, Marijuana Abuse, Substance-Related Disorders

Keywords

alcohol dependence, marijuana dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

126 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

fluoxetine + CBT

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo + CBT

Intervention Type

Drug

Intervention Name(s)

Fluoxetine + outpatient cognitive behavioral therapy

Other Intervention Name(s)

Prozac

Intervention Description

single fixed morning dose 20 mg X 15 weeks

Intervention Type

Drug

Intervention Name(s)

fluoxetine

Other Intervention Name(s)

prozac

Intervention Description

20mg, QD x 16 weeks

Intervention Type

Drug

Intervention Name(s)

placebo + CBT

Intervention Description

single fixed morning dose X 16 weeks

Primary Outcome Measure Information:

Title

To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems.

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paula Riggs, M.D.

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Colorado Denver

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

1611 South Federal Blvd.

City

Denver

State/Province

Colorado

ZIP/Postal Code

80219

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

10698377

Citation

Deas D, Riggs P, Langenbucher J, Goldman M, Brown S. Adolescents are not adults: developmental considerations in alcohol users. Alcohol Clin Exp Res. 2000 Feb;24(2):232-7.

Results Reference

background

PubMed Identifier

11389804

Citation

Davies RD, Gabbert SL, Riggs PD. Anxiety Disorders in Neurologic Illness. Curr Treat Options Neurol. 2001 Jul;3(4):333-346. doi: 10.1007/s11940-001-0038-1.

Results Reference

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PubMed Identifier

12364848

Citation

Riggs PD, Davies RD. A clinical approach to integrating treatment for adolescent depression and substance abuse. J Am Acad Child Adolesc Psychiatry. 2002 Oct;41(10):1253-5. doi: 10.1097/00004583-200210000-00016. No abstract available.

Results Reference

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PubMed Identifier

18552718

Citation

Riggs PD. Treating adolescents for substance abuse and comorbid psychiatric disorders. Sci Pract Perspect. 2003 Aug;2(1):18-29. doi: 10.1151/spp032118.

Results Reference

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Citation

Laudenslager, M.L., Neu, M., Riggs, P., Goldstein, M., & Lohman, M. Refinements in a novel technique for collecting saliva for steroid hormone determinations. Brain Behavior, and Immunity, 17 (3), 186, 2003.

Results Reference

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PubMed Identifier

15187802

Citation

Riggs PD, Hall SK, Mikulich-Gilbertson SK, Lohman M, Kayser A. A randomized controlled trial of pemoline for attention-deficit/hyperactivity disorder in substance-abusing adolescents. J Am Acad Child Adolesc Psychiatry. 2004 Apr;43(4):420-9. doi: 10.1097/00004583-200404000-00008.

Results Reference

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PubMed Identifier

15279762

Citation

Davies RD, Thurstone C, Woyewodzic K. Substance Use Disorders and Neurologic Illness. Curr Treat Options Neurol. 2004 Sep;6(5):421-432. doi: 10.1007/s11940-996-0032-8.

Results Reference

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PubMed Identifier

16098679

Citation

Libby AM, Orton HD, Stover SK, Riggs PD. What came first, major depression or substance use disorder? Clinical characteristics and substance use comparing teens in a treatment cohort. Addict Behav. 2005 Oct;30(9):1649-62. doi: 10.1016/j.addbeh.2005.07.012. Epub 2005 Aug 11.

Results Reference

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PubMed Identifier

16262598

Citation

Libby AM, Riggs PD. Integrated substance use and mental health treatment for adolescents: aligning organizational and financial incentives. J Child Adolesc Psychopharmacol. 2005 Oct;15(5):826-34. doi: 10.1089/cap.2005.15.826.

Results Reference

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PubMed Identifier

17003670

Citation

Drell MJ, Josephson A, Pleak R, Riggs P, Rosenfeld A. Clinical problem solving: the case of John, Part II: excerpts from Sessions 2-7. J Am Acad Child Adolesc Psychiatry. 2006 Oct;45(10):1243-51. doi: 10.1097/01.chi.0000230164.46493.8c. No abstract available.

Results Reference

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PubMed Identifier

17712241

Citation

Thurstone C, Riggs PD, Klein C, Mikulich-Gilbertson SK. A one-session human immunodeficiency virus risk-reduction intervention in adolescents with psychiatric and substance use disorders. J Am Acad Child Adolesc Psychiatry. 2007 Sep;46(9):1179-1186. doi: 10.1097/chi.0b013e31809fe774.

Results Reference

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PubMed Identifier

18267053

Citation

Riggs P. Non-medical use and abuse of commonly prescribed medications. Curr Med Res Opin. 2008 Mar;24(3):869-77. doi: 10.1185/030079908X273435. Epub 2008 Feb 8.

Results Reference

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PubMed Identifier

17984403

Citation

Riggs PD, Mikulich-Gilbertson SK, Davies RD, Lohman M, Klein C, Stover SK. A randomized controlled trial of fluoxetine and cognitive behavioral therapy in adolescents with major depression, behavior problems, and substance use disorders. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1026-34. doi: 10.1001/archpedi.161.11.1026.

Results Reference

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PubMed Identifier

18038460

Citation

Riggs PD, Thompson LL, Tapert SF, Frascella J, Mikulich-Gilbertson S, Dalwani M, Laudenslager M, Lohman M. Advances in neurobiological research related to interventions in adolescents with substance use disorders: research to practice. Drug Alcohol Depend. 2007 Dec 1;91(2-3):306-11. doi: 10.1016/j.drugalcdep.2007.03.003. No abstract available.

Results Reference

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Substance Dependent Teens - Impact of Treating Depression Study 1 - 1

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