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Alcohol-Related DisordersPhase 4NCT00061113

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

A Phase 4 study testing Fluoxetine + outpatient cognitive behavioral therapy and fluoxetine in people with Alcohol-Related Disorders and Marijuana Abuse, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 13 to 19 years
What is being tested?
Fluoxetine + outpatient cognitive behavioral therapy and fluoxetine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
2 sitesUnited States
Study dates
Feb 2001to Aug 2006
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Must have DSM IV non bipolar Major Depressive disorder (by clinical interview), DSM IV Conduct Disorder, and Non-Tobacco Substance Disorder.

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • 1611 South Federal Blvd.

    Denver, Colorado, 80219

Other trials in United States

About this study

Official title: Substance Dependent Teens - Impact of Treating Depression Study 1

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

Read the 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.

Being tested
Fluoxetine + outpatient cognitive behavioral therapy, fluoxetine, placebo + CBT
Keywords
alcohol dependence, marijuana dependence
Medical subject headings
Alcohol-Related Disorders, Marijuana Abuse, Substance-Related Disorders, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluoxetine + outpatient cognitive behavioral therapyDrug

    Also called Prozac

    single fixed morning dose 20 mg X 15 weeks

  • fluoxetineDrug

    Also called prozac

    20mg, QD x 16 weeks

  • placebo + CBTDrug

    single fixed morning dose X 16 weeks

Study groups in NCT00061113
Study groupRoleWhat they receive
1Active comparatorfluoxetine + CBT
Receives: Drug: Fluoxetine + outpatient cognitive behavioral therapy; Drug: fluoxetine
2Placebo comparatorplacebo + CBT
Receives: Drug: placebo + CBT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 16 weeks

Secondary outcomes (1)

  1. 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.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2003 (estimated)
  2. Study startFeb 2001
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00061113
Sponsor's protocol ID
NIDA-13176-1
Other IDs
R01-13176-1
Status last verified
Sep 2008
First submitted
21 May 2003
Last updated
12 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10698377

  • 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.

    PubMed 11389804

  • 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.

    PubMed 12364848

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

    PubMed 18552718

  • 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.

  • 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.

    PubMed 15187802

  • 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.

    PubMed 15279762

  • 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.

    PubMed 16098679

  • 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.

    PubMed 16262598

  • 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.

    PubMed 17003670

  • 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.

    PubMed 17712241

  • 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.

    PubMed 18267053

  • 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.

    PubMed 17984403

  • 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.

    PubMed 18038460

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluoxetine + outpatient cognitive behavioral therapy and fluoxetine in people with Alcohol-Related Disorders and Marijuana Abuse, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine whether fluoxetine + CBT is a more effective treatment than placebo + CBT for substance outcomes, depression, and behavior problems. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00061113, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.

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