Cocaine DependencePhase 2NCT00913484
Disulfiram for Cocaine Abuse in Buprenorphine Treatment
A Phase 2 study testing Disulfiram in people with Cocaine Dependence and Opioid Dependency, run by Yale University at 2 sites in United States.
Trial summary
The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cocaine Dependence, Opioid Dependency
- What is being tested?
- Disulfiram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2000to Feb 2004
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- English speaking adults ages 18 - 45.
- Meeting FDA criteria for agonist maintenance treatment and DSM-IV criteria for opioid dependence and cocaine dependence or abuse as assessed by SCID interview and documented by opioid positive and cocaine positive urine toxicology testing.
- Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy testing during the course of the study.
Who cannot join
- Current physiologic dependence on benzodiazepines or alcohol, unless first detoxified. Subjects who use/abuse alcohol will be included but will be cautioned about alcohol use during the study because of the possibility of an alcohol-disulfiram reaction.
- Use of the antibiotic agents metronidazole or clotrimazole, which have disulfiram-like effects in combination with alcohol.
- Presence of significant cardiovascular, renal, hepatic or neurologic illness. Subjects with markedly abnormal liver function tests (i.e., AST of ALT > 3X normal) will also be excluded.
- Presence of any of the following cardiovascular risk factors:
- age > 45 years
- history of cocaine-related chest pain
Show all 13Show fewer
- systolic blood pressure > 140 or diastolic blood pressure > 90
- evidence of ischemia or past myocardial infarction on EKG
- significant family history of risk (first degree relative with myocardial infarction prior to age 60)
- elevated cholesterol (> 300 mg/dl), elevated LDL (> 170 mg/dl) or low HDL (< 20 mg/dl)
- Maintenance on methadone at doses greater than 30mg daily. Admittance to the study will only be offered to individuals who have been maintained on 30 mg of methadone or less daily for seven days prior to entering the study.
- Current suicide or homicide risk or current psychotic disorder.
- Inability to read or understand the symptom checklists.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The APT Foundation MRU
New Haven, Connecticut, 06519
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.
Read the detailed description
The Specific Aims and hypotheses for the proposed study are as follows:
- To compare the efficacy of disulfiram versus placebo for the treatment of buprenorphine maintained patients with concurrent opioid and cocaine dependence. Study hypothesis 1 is that disulfiram is superior to placebo.
- To evaluate whether dopamine-B-hydroxylase (DBH) genotypes associated with high, intermediate or low enzyme activity predict responses to disulfiram treatment of cocaine use in buprenorphine treated subjects. Study hypothesis 2 is that disulfiram efficacy is higher in subjects with low DBH compared to subjects with high DBH.
- To explore whether baseline measures of alcohol use predict response to disulfiram. Study Hypothesis 3 is that the effects of disulfiram on cocaine use are independent of the severity of baseline alcohol use.
- Conditions
- Cocaine Dependence, Opioid Dependency
- Being tested
- Disulfiram, Placebo
- Keywords
- Disulfiram, Buprenorphine, Cocaine dependence, Opioid dependence, Dopamine-Beta-Hydroxylase
- 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
Disulfiram 250 mg per day
PlaceboDrug
Placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Disulfiram | Experimental | Disulfiram 250 mg per day Receives: Drug: Disulfiram |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine abstinence
Measured: 12 weeks
Secondary outcomes (1)
Opioid abstinence
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startOct 2000
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Richard S. Schottenfeld, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913484
- Sponsor's protocol ID
- 1R01DA012979
- Other IDs
- 1R01DA012979
- Status last verified
- Nov 2020
- First submitted
- 3 Jun 2009
- Last updated
- 19 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disulfiram for Cocaine Abuse in Buprenorphine Treatment
- ClinicalTrials.gov ID
- NCT00913484
- Acronym / sponsor ID
- 1R01DA012979
- Conditions
- Cocaine Dependence, Opioid Dependency
- Keywords
- Disulfiram, Buprenorphine, Cocaine dependence, Opioid dependence, Dopamine-Beta-Hydroxylase
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2000
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 4 Jun 2009 (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.
The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on buprenorphine/naloxone combination.
Detailed description
The Specific Aims and hypotheses for the proposed study are as follows:
- To compare the efficacy of disulfiram versus placebo for the treatment of buprenorphine maintained patients with concurrent opioid and cocaine dependence. Study hypothesis 1 is that disulfiram is superior to placebo.
- To evaluate whether dopamine-B-hydroxylase (DBH) genotypes associated with high, intermediate or low enzyme activity predict responses to disulfiram treatment of cocaine use in buprenorphine treated subjects. Study hypothesis 2 is that disulfiram efficacy is higher in subjects with low DBH compared to subjects with high DBH.
- To explore whether baseline measures of alcohol use predict response to disulfiram. Study Hypothesis 3 is that the effects of disulfiram on cocaine use are independent of the severity of baseline alcohol use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disulfiram | Experimental | Drug: DisulfiramDisulfiram 250 mg per day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English speaking adults ages 18 - 45.
- Meeting FDA criteria for agonist maintenance treatment and DSM-IV criteria for opioid dependence and cocaine dependence or abuse as assessed by SCID interview and documented by opioid positive and cocaine positive urine toxicology testing.
- Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy testing during the course of the study.
Key exclusion criteria (13 listed)
- Current physiologic dependence on benzodiazepines or alcohol, unless first detoxified. Subjects who use/abuse alcohol will be included but will be cautioned about alcohol use during the study because of the possibility of an alcohol-disulfiram reaction.
- Use of the antibiotic agents metronidazole or clotrimazole, which have disulfiram-like effects in combination with alcohol.
- Presence of significant cardiovascular, renal, hepatic or neurologic illness. Subjects with markedly abnormal liver function tests (i.e., AST of ALT > 3X normal) will also be excluded.
- Presence of any of the following cardiovascular risk factors:
- Maintenance on methadone at doses greater than 30mg daily. Admittance to the study will only be offered to individuals who have been maintained on 30 mg of methadone or less daily for seven days prior to entering the study.
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 |
|---|---|---|
| DisulfiramDisulfiram 250 mg per day | Drug | Disulfiram |
| PlaceboPlacebo daily | Drug | Placebo |
Primary outcome
Cocaine abstinence
Time frame: 12 weeks
1 secondary outcome
Opioid abstinence
Time frame: 12 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 19 Nov 2020.
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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.
Richard S. Schottenfeld, M.D. principal investigator
Yale University
2 sites 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 Dependence and Opioid Dependency, run by Yale University at 2 sites 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 13 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 abstinence (time frame: 12 weeks). 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 19 Nov 2020.