NCT00018824

Brief Summary

The purpose of this study is to test the efficacy combining a treatment for depression with a treatment for alcohol dependence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 5, 2001

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

September 23, 2009

Status Verified

September 1, 2009

Enrollment Period

5.3 years

First QC Date

July 3, 2001

Last Update Submit

September 21, 2009

Conditions

AlcoholismDepression

Outcome Measures

Primary Outcomes (1)

  • Alcohol use'

    12 weeks

Study Arms (2)

1

EXPERIMENTAL

Naltrexone

Drug: NALTREXONE

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NALTREXONEDRUG
1
PlaceboDRUG
2

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 55
  • Current depressive syndrome
  • Current alcohol dependence
  • No psychosis
  • No opioid or cocaine abuse or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Oslin DW. Treatment of late-life depression complicated by alcohol dependence. Am J Geriatr Psychiatry. 2005 Jun;13(6):491-500. doi: 10.1176/appi.ajgp.13.6.491.

    PMID: 15956269RESULT

MeSH Terms

Conditions

AlcoholismDepression

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • David W. Oslin, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

July 3, 2001

First Posted

July 5, 2001

Study Start

October 1, 1999

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

September 23, 2009

Record last verified: 2009-09

Locations

US(1)