Cocaine-Related DisordersPhase 2NCT00249483
Venlafaxine to Reduce Cocaine Dependence in Depressed Individuals
A Phase 2 study testing Venlafaxine in people with Cocaine-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine-Related Disorders
- What is being tested?
- Venlafaxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Feb 2005
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Placebo-Controlled Venlafaxine Treatment for Depressed Cocaine Abusers
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.
Read the detailed 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.
- Conditions
- Cocaine-Related Disorders
- Being tested
- Venlafaxine, Placebo
- Keywords
- Cocaine Addiction, Cocaine Dependence
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Venlafaxiine 300mg/day
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Venlafaxine | Experimental | Venlafaxine 300mg daily Receives: Drug: Venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine use
Proportion of patients achieving 3 weeks of cocaine abstinence based on self report and urine toxicology
Measured: 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
Measured: baseline compared to week 12 or last week of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startOct 1999
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Herbert Kleber, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249483
- Sponsor's protocol ID
- #4706R NIDA-09236-14
- Other IDs
- P50DA009236
- Status last verified
- Jul 2017
- First submitted
- 3 Nov 2005
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Venlafaxine Treatment for Depressed Cocaine Abusers
- ClinicalTrials.gov ID
- NCT00249483
- Acronym / sponsor ID
- #4706R NIDA-09236-14
- Conditions
- Cocaine-Related Disorders
- Keywords
- Cocaine Addiction, Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 1999
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Venlafaxine | Experimental | Drug: VenlafaxineVenlafaxine 300mg daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenlafaxineVenlafaxiine 300mg/day | Drug | Venlafaxine |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Cocaine use
Time frame: baseline compared to 12 weeks of study or length of participation
Proportion of patients achieving 3 weeks of cocaine abstinence based on self report and urine toxicology
Hamilton Depression Rating Scale
Time frame: baseline compared to week 12 or last week of study participation
Proportion of patients achieving a 50% reduction in HAM-D score at week 12 compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert Kleber, MD principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Venlafaxine in people with Cocaine-Related Disorders, run by New York State Psychiatric Institute at 1 site 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 4 inclusion and 14 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 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Cocaine use (time frame: baseline compared to 12 weeks of study or length of participation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jul 2017.