NCT00249483

Brief Summary

Preliminary research has shown that venlafaxine, a medication currently used for treating depression, may also discourage cocaine use in depressed individuals. This study will evaluate the effectiveness of venlafaxine in reducing cocaine use and alleviating depression in individuals addicted to cocaine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 1999

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

5.3 years

First QC Date

November 3, 2005

Last Update Submit

July 6, 2017

Conditions

Cocaine-Related Disorders

Keywords

Cocaine AddictionCocaine Dependence

Outcome Measures

Primary Outcomes (2)

  • Cocaine use

    Proportion of patients achieving 3 weeks of cocaine abstinence based on self report and urine toxicology

    baseline compared to 12 weeks of study or length of participation

  • Hamilton Depression Rating Scale

    Proportion of patients achieving a 50% reduction in HAM-D score at week 12 compared to baseline

    baseline compared to week 12 or last week of study participation

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Venlafaxine

EXPERIMENTAL

Venlafaxine 300mg daily

Drug: Venlafaxine

Interventions

VenlafaxineDRUG

Venlafaxiine 300mg/day

Venlafaxine
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Meets DSM-IV diagnosis criteria for current cocaine dependence
  • Used cocaine at least one day in the month prior to study entry
  • Meets DSM-IV criteria for major depression or dysthymia, with depression either primary (predates earliest life-time substance abuse), depression persistent during 6 months of cocaine abstinence in the past, or depression for at least 3 months prior to study entry
  • If female, willing to use contraception throughout the study

You may not qualify if:

  • Meets DSM-IV diagnosis criteria for bipolar disorder, schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
  • Chronic organic mental disorder
  • Significant risk of suicide, based on current mental state or history
  • Untreated seizure disorder or history of substance-related seizures
  • Unstable physical disorders that may make study participation dangerous, including hypertension, hepatitis (mildly elevated transaminase levels that are less than 4 times the upper limit or normal levels are acceptable), and diabetes
  • Coronary vascular disease, as indicated by medical history, suspected by abnormal ECG, or history of heart symptoms
  • Irregular heartbeat as indicated by QRS duration greater than 0.11
  • Current use of other prescribed psychotropic medications
  • Currently meets DSM-IV diagnosis criteria for dependence on any drugs other than nicotine, marijuana, or alcohol
  • History of allergic or adverse reaction to desipramine or venlafaxine
  • Prior history of failing to respond to venlafaxine
  • History of alcohol withdrawal syndrome in the year prior to study entry
  • Current evidence of alcohol withdrawal, such as pulse rate greater than 115 beats per minute, blood pressure greater than 140/90 mm Hg, or visible tremors
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsPhenethylaminesEthylaminesAminesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsLipids

Study Officials

  • Herbert Kleber, MD

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

October 1, 1999

Primary Completion

February 1, 2005

Study Completion

February 1, 2005

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

US(1)