Cocaine-Related DisordersPhase 2NCT00218608
Disulfiram for Treating Cocaine Dependence in Individuals Maintained on Methadone
A Phase 2 study testing Disulfiram in people with Cocaine-Related Disorders and Opioid-Related Disorders, run by University of Arkansas at 1 site in United States.
Trial summary
Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used in several different forms and can be snorted, smoked, or injected to achieve the desired effect. Cocaine users are at risk for many health problems, both directly and indirectly related to the effects of cocaine. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine-Related Disorders, Opioid-Related Disorders
- What is being tested?
- Disulfiram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2001to Jan 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- History of cocaine use at least once a week during the month prior to study entry
- Urine screen tests positive for cocaine
- Meets DSM-IV criteria for opioid- and cocaine-dependence
- Urine toxicology screen tests negative for benzodiazepines prior to beginning methadone treatment
Who cannot join
- Current drug or alcohol dependence other than opiates, cocaine, or tobacco
- Significant medical condition, such as abnormal liver function (with laboratory findings greater than three times normal), active hepatitis, or high blood pressure
- Current cardiac condition
- Occult coronary artery disease
- At high risk for cardiovascular disease, seizure disorders, or any other significant underlying medical condition that may make treatment with disulfiram or methadone unsafe
- Meets DSM-IV psychiatric diagnostic criteria for lifetime schizophrenia, bipolar disorder, or other psychotic disorders
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- Currently suicidal or homicidal
- Currently taking a prescribed psychotropic medication that cannot be discontinued
- Pregnant
- Currently taking metronidazole or clotrimazole
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205 7911
About this study
Official title: Disulfiram for Cocaine Abuse in Methadone- Patients
Cocaine is an extremely addictive stimulant drug that directly affects the brain. It is used in several different forms and can be snorted, smoked, or injected to achieve the desired effect. Cocaine users are at risk for many health problems, both directly and indirectly related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may be effective in reducing cocaine use. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.
Read the detailed description
Despite the harm that cocaine can cause to the body, its abuse is widespread. It is the cause of more visits to hospital emergency rooms nationwide than any other illegal drug. Effective treatments for cocaine and opiate addictions are essential to the decline of cocaine- and opiate-related disorders. Unfortunately, cocaine use remains prevalent among participants in many opioid maintenance programs. The addition of other medications to methadone maintenance may prove helpful in reducing cocaine use. Disulfiram, a drug used to treat chronic alcoholism, causes unpleasant effects when even small amounts of alcohol are consumed. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.
Participants in this double blind study will be randomly assigned to receive either disulfiram at one of three dosage levels (62.5, 125, 250 mg/day) or placebo for 14 weeks. During the first 2 weeks, doses of methadone plus either disulfiram or placebo will be administered until the assigned maintenance dose is achieved. This dosage level will be maintained for the duration of the study. Participants will be required to report to the study site Monday through Saturday of each week for assessments and to receive medication. They will receive a take-home dose of medication for Sunday. In addition, participants will receive a weekly session of cognitive-behavioral therapy. Urine samples will be collected three times a week to assess drug use. At the end of the study, participants will undergo a 4- to 6-week detoxification period in which they will gradually discontinue the use of methadone and disulfiram. All participants have the option to request transfer to a local methadone maintenance program instead of undergoing detoxification.
Enrollment has been completed and no subjects are active. Data analyses are being conducted at this time.
- Being tested
- Disulfiram
- Keywords
- Cocaine Abuse
- 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.
DisulfiramDrug
Also called Antabuse
Disulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (microcrystalline cellulose) was suspended in the methadone during weeks 3-14. Receives: Drug: Disulfiram |
| Disulfiram at 62.5 mg | Active comparator | Disulfiram at 62.5 mg was suspended in the methadone during weeks 3-14. Receives: Drug: Disulfiram |
| Disulfiram at 125 mg | Active comparator | Disulfiram at 125 mg/day was suspended in methadone during weeks 3-14. Receives: Drug: Disulfiram |
| Disulfiram at 250 mg | Active comparator | Disulfiram at 250 mg/day was suspended in methadone during weeks 3-14. Receives: Drug: Disulfiram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine use
Urine toxicology screens were conducted thrice-weekly for 14 weeks.
Measured: 14 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startApr 2001
- Primary completionJan 2007
- Study completionJan 2007
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.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Alison Oliveto, PhD, Principal investigator, UAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218608
- Sponsor's protocol ID
- NIDA-13441-1
- Other IDs
- R01-13441-1, DPMC
- Status last verified
- Jan 2012
- First submitted
- 20 Sep 2005
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disulfiram for Cocaine Abuse in Methadone- Patients
- ClinicalTrials.gov ID
- NCT00218608
- Acronym / sponsor ID
- NIDA-13441-1
- Keywords
- Cocaine Abuse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- Apr 2001
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 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 is an extremely addictive stimulant drug that directly affects the brain. It is used in several different forms and can be snorted, smoked, or injected to achieve the desired effect. Cocaine users are at risk for many health problems, both directly and indirectly related to the effects of cocaine. Disulfiram, a drug used to treat chronic alcoholism, may be effective in reducing cocaine use. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.
Detailed description
Despite the harm that cocaine can cause to the body, its abuse is widespread. It is the cause of more visits to hospital emergency rooms nationwide than any other illegal drug. Effective treatments for cocaine and opiate addictions are essential to the decline of cocaine- and opiate-related disorders. Unfortunately, cocaine use remains prevalent among participants in many opioid maintenance programs. The addition of other medications to methadone maintenance may prove helpful in reducing cocaine use. Disulfiram, a drug used to treat chronic alcoholism, causes unpleasant effects when even small amounts of alcohol are consumed. This study will evaluate the effectiveness of three different doses of disulfiram in treating cocaine dependence in opioid- and cocaine-dependent individuals maintained on methadone.
Participants in this double blind study will be randomly assigned to receive either disulfiram at one of three dosage levels (62.5, 125, 250 mg/day) or placebo for 14 weeks. During the first 2 weeks, doses of methadone plus either disulfiram or placebo will be administered until the assigned maintenance dose is achieved. This dosage level will be maintained for the duration of the study. Participants will be required to report to the study site Monday through Saturday of each week for assessments and to receive medication. They will receive a take-home dose of medication for Sunday. In addition, participants will receive a weekly session of cognitive-behavioral therapy. Urine samples will be collected three times a week to assess drug use. At the end of the study, participants will undergo a 4- to 6-week detoxification period in which they will gradually discontinue the use of methadone and disulfiram. All participants have the option to request transfer to a local methadone maintenance program instead of undergoing detoxification.
Enrollment has been completed and no subjects are active. Data analyses are being conducted at this time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: DisulfiramPlacebo (microcrystalline cellulose) was suspended in the methadone during weeks 3-14. |
| Disulfiram at 62.5 mg | Active comparator | Drug: DisulfiramDisulfiram at 62.5 mg was suspended in the methadone during weeks 3-14. |
| Disulfiram at 125 mg | Active comparator | Drug: DisulfiramDisulfiram at 125 mg/day was suspended in methadone during weeks 3-14. |
| Disulfiram at 250 mg | Active comparator | Drug: DisulfiramDisulfiram at 250 mg/day was suspended in methadone during weeks 3-14. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of cocaine use at least once a week during the month prior to study entry
- Urine screen tests positive for cocaine
- Meets DSM-IV criteria for opioid- and cocaine-dependence
- Urine toxicology screen tests negative for benzodiazepines prior to beginning methadone treatment
Key exclusion criteria (10 listed)
- Current drug or alcohol dependence other than opiates, cocaine, or tobacco
- Significant medical condition, such as abnormal liver function (with laboratory findings greater than three times normal), active hepatitis, or high blood pressure
- Current cardiac condition
- Occult coronary artery disease
- At high risk for cardiovascular disease, seizure disorders, or any other significant underlying medical condition that may make treatment with disulfiram or methadone unsafe
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 |
|---|---|---|
| DisulfiramAlso: AntabuseDisulfiram at 0, 62.5, 125 and 250 mg/day were administered during weeks 3-14 | Drug | Disulfiram at 125 mg, Disulfiram at 250 mg, Disulfiram at 62.5 mg, Placebo |
Primary outcome
Cocaine use
Time frame: 14 wks
Urine toxicology screens were conducted thrice-weekly for 14 weeks.
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 31 Jan 2012.
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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.
Alison Oliveto, PhD principal investigator
UAMS
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 Disulfiram in people with Cocaine-Related Disorders and Opioid-Related Disorders, run by University of Arkansas 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 10 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 31 Jan 2012. 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: 14 wks). 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 31 Jan 2012.