Cocaine-Related DisordersNCT00142779
Fluoxetine to Reduce Cocaine Use in Cocaine and Opioid Addicts
A study testing Fluoxetine in people with Cocaine-Related Disorders and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Fluoxetine, a medication that is currently used to treat depression and anxiety disorders, may also be effective at diminishing cocaine use in individuals with severe cocaine addiction. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cocaine-Related Disorders, Opioid-Related Disorders
- What is being tested?
- Fluoxetine
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Mar 2006
- Phase
- Interventional
- 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
- Currently dependent on opioids
- Currently dependent on cocaine
- Eligible to receive methadone maintenance treatment
Who cannot join
- Current significant medical or psychiatric illness
- Current use of a specific serotonin reuptake inhibitor (SSRI)
- History of allergy to SSRI medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21224
About this study
Official title: Serotonin Treatment of Cocaine Dependence
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Fluoxetine, a medication that is currently used to treat depression and anxiety disorders, may also be effective at diminishing cocaine use in individuals with severe cocaine addiction. This study will evaluate the effectiveness of fluoxetine at reducing cocaine use in individuals addicted to cocaine and opioids who are concurrently receiving methadone treatment.
Read the detailed description
Individuals addicted to cocaine often experience feelings of restlessness, irritability, anxiety, and paranoia. Reducing cocaine use can lead to depression. In an attempt to alleviate the depressive symptoms, individuals may resume drug use. Fluoxetine, a medication that is currently used to treat depression and panic attacks, may assist at reducing cocaine use in individuals addicted to cocaine. By increasing serotonin, a chemical in the brain that helps maintain mental balance, fluoxetine may lessen depressive symptoms and decrease the reinforcing effects of cocaine. Voucher incentive programs, in which items or services are offered as a reward for remaining drug-free, are also a useful component of substance abuse treatment. Preliminary research has shown that fluoxetine, when combined with an incentive program, is an effective treatment for reducing cocaine use. Further research is needed to confirm the benefits of fluoxetine for cocaine and opioid addicts. The purpose of this study is to evaluate the effectiveness of fluoxetine, in combination with a voucher incentive program, at reducing cocaine use in methadone-maintained cocaine and opioid addicts.
This 33-week study will enroll individuals addicted to both cocaine and opioids who are concurrently enrolled in a methadone treatment program. Participants will be randomly assigned to receive either 60 mg of fluoxetine or placebo on a daily basis for 12 weeks from Weeks 8 through 19. Study visits will occur once a week. Questionnaires and self-reports will be completed to assess medication side effects and cocaine use. Cocaine levels will be monitored three times a week with urine tests. During the 12 weeks of treatment, participants will also be randomly assigned to either take part in a voucher incentives program or not take part in the program. Participants in the voucher program will receive a voucher that may be exchanged for various items and services for each urine test with a negative cocaine result.
- Being tested
- Fluoxetine
- Keywords
- Cocaine Addiction, Cocaine Dependence, Opiate Addiction, Opiate Dependence
- Medical subject headings
- Cocaine-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoxetineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine use (measured by urine screen and self-report at Week 19 and 33)
Medication side effects (measured by self-reports throughout Weeks 8 through 19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startApr 2001
- Primary completionJan 2006
- Study completionMar 2006
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 220 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Eric C. Strain, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142779
- Sponsor's protocol ID
- NIDA-10754-2
- Other IDs
- R01-10754-2, DPMC
- Status last verified
- May 2009
- First submitted
- 1 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin Treatment of Cocaine Dependence
- ClinicalTrials.gov ID
- NCT00142779
- Acronym / sponsor ID
- NIDA-10754-2
- Keywords
- Cocaine Addiction, Cocaine Dependence, Opiate Addiction, Opiate Dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2001
- Primary completion
- Jan 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 2 Sep 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.
Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Fluoxetine, a medication that is currently used to treat depression and anxiety disorders, may also be effective at diminishing cocaine use in individuals with severe cocaine addiction. This study will evaluate the effectiveness of fluoxetine at reducing cocaine use in individuals addicted to cocaine and opioids who are concurrently receiving methadone treatment.
Detailed description
Individuals addicted to cocaine often experience feelings of restlessness, irritability, anxiety, and paranoia. Reducing cocaine use can lead to depression. In an attempt to alleviate the depressive symptoms, individuals may resume drug use. Fluoxetine, a medication that is currently used to treat depression and panic attacks, may assist at reducing cocaine use in individuals addicted to cocaine. By increasing serotonin, a chemical in the brain that helps maintain mental balance, fluoxetine may lessen depressive symptoms and decrease the reinforcing effects of cocaine. Voucher incentive programs, in which items or services are offered as a reward for remaining drug-free, are also a useful component of substance abuse treatment. Preliminary research has shown that fluoxetine, when combined with an incentive program, is an effective treatment for reducing cocaine use. Further research is needed to confirm the benefits of fluoxetine for cocaine and opioid addicts. The purpose of this study is to evaluate the effectiveness of fluoxetine, in combination with a voucher incentive program, at reducing cocaine use in methadone-maintained cocaine and opioid addicts.
This 33-week study will enroll individuals addicted to both cocaine and opioids who are concurrently enrolled in a methadone treatment program. Participants will be randomly assigned to receive either 60 mg of fluoxetine or placebo on a daily basis for 12 weeks from Weeks 8 through 19. Study visits will occur once a week. Questionnaires and self-reports will be completed to assess medication side effects and cocaine use. Cocaine levels will be monitored three times a week with urine tests. During the 12 weeks of treatment, participants will also be randomly assigned to either take part in a voucher incentives program or not take part in the program. Participants in the voucher program will receive a voucher that may be exchanged for various items and services for each urine test with a negative cocaine result.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Currently dependent on opioids
- Currently dependent on cocaine
- Eligible to receive methadone maintenance treatment
Key exclusion criteria (3 listed)
- Current significant medical or psychiatric illness
- Current use of a specific serotonin reuptake inhibitor (SSRI)
- History of allergy to SSRI medications
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 |
|---|---|---|
| Fluoxetine | Drug | – |
Primary outcome
Cocaine use (measured by urine screen and self-report at Week 19 and 33)
Medication side effects (measured by self-reports throughout Weeks 8 through 19)
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 12 Jan 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.
Eric C. Strain, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine in people with Cocaine-Related Disorders and Opioid-Related Disorders, run by National Institute on Drug Abuse (NIDA) 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 3 inclusion and 3 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 (measured by urine screen and self-report at Week 19 and 33). 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 12 Jan 2017.