Venlafaxine to Reduce Cocaine Dependence in Depressed Individuals

New York State Psychiatric Institute

Status and phase

Completed

Phase 2

Conditions

Cocaine-Related Disorders

Treatments

Drug: Placebo

Drug: Venlafaxine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00249483

P50DA009236 (U.S. NIH Grant/Contract)

#4706R NIDA-09236-14

Details and patient eligibility

About

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.

Full description

Individuals addicted to cocaine often experience feelings of restlessness, irritability, and anxiety. They also often report feeling depressed when not using cocaine, and they tend to resume cocaine use to alleviate symptoms of depression. Venlafaxine is a medication that is currently used to treat depression and anxiety disorders. Preliminary research has shown that venlafaxine reduces depression, improves mood, and simultaneously reduces cocaine use in cocaine addicts. Further research is needed to confirm the benefits of venlafaxine for cocaine addicts. The purpose of this study is to evaluate the effectiveness of venlafaxine in reducing cocaine use, cocaine craving, and depression in individuals who are addicted to cocaine and diagnosed with depression.

This study will begin with a 1-week lead-in phase, during which all participants will receive placebo medication. Participants whose depression levels decrease will not continue in the treatment phase of the study, but will be eligible for cocaine relapse therapy and medication if deemed necessary by the treating psychiatrist. Participants who remain depressed following the lead-in phase will be randomly assigned to receive either venlafaxine or placebo for 12 weeks. Participants assigned to venlafaxine will initially receive a daily dose of 37.5 mg. After 4 days, the dose will be increased to 75 mg; each week thereafter, the dose will be increased by another 75 mg, up to a maximum of 300 mg per day, dependent on side effects and positive responses. Study visits will take place twice a week. At each visit, medication side effects and depression levels will be assessed, cocaine levels will be monitored with urine tests, and self-reports will be completed. Blood will be drawn once per month for laboratory tests. Participants will also attend a therapy session once a week, and they will meet with a psychiatrist every other week for assessments. Participants who show a decrease in depression during the 12 weeks of treatment will continue for an additional 12 weeks to further monitor cocaine use and depression levels.

Enrollment

150 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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