Opioid DependencePhase 1NCT00292123
Combined Behavioral and Pharmacologic Treatment of Polydrug Abuse
A Phase 1 study testing Methadone and Contingency Management in people with Opioid Dependence and Cocaine Abuse, run by National Institute on Drug Abuse (NIDA).
Trial summary
The primary goal of this study is to determine how contingency management can best be combined with standard or high doses of methadone to increase simultaneous abstinence from heroin and cocaine. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Dependence, Cocaine Abuse
- What is being tested?
- Methadone and Contingency Management
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 1999to Aug 2006
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Opioid dependence; cocaine use
Who cannot join
- Medical or psychiatric conditions that would contraindicate participation in a methadone maintenance study; inability to give informed consent; inability to attend clinic seven days a week
About this study
The primary goal of this study is to determine how contingency management can best be combined with standard or high doses of methadone to increase simultaneous abstinence from heroin and cocaine.
Read the detailed description
A study of people pmaintained on Methadone using contingency management
- Conditions
- Opioid Dependence, Cocaine Abuse
- Being tested
- Methadone, Contingency Management
- Medical subject headings
- Opioid-Related Disorders, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Contingency ManagementBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2006 (estimated)
- Study startJun 1999
- Primary completionJun 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Opioid DependenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Kenzie Preston, PhD, Principal investigator, NIFA Intramural Research Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00292123
- Sponsor's protocol ID
- NIDAIRP 326
- Status last verified
- Dec 2007
- First submitted
- 14 Feb 2006
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ghitza UE, Epstein DH, Preston KL. Contingency management reduces injection-related HIV risk behaviors in heroin and cocaine using outpatients. Addict Behav. 2008 Apr;33(4):593-604. doi: 10.1016/j.addbeh.2007.11.009. Epub 2007 Nov 17.
PubMed 18068905Willner-Reid J, Belendiuk KA, Epstein DH, Schmittner J, Preston KL. Hepatitis C and human immunodeficiency virus risk behaviors in polydrug users on methadone maintenance. J Subst Abuse Treat. 2008 Jul;35(1):78-86. doi: 10.1016/j.jsat.2007.08.011. Epub 2007 Oct 10.
PubMed 17931826Ghitza UE, Epstein DH, Schmittner J, Vahabzadeh M, Lin JL, Preston KL. Randomized trial of prize-based reinforcement density for simultaneous abstinence from cocaine and heroin. J Consult Clin Psychol. 2007 Oct;75(5):765-74. doi: 10.1037/0022-006X.75.5.765.
PubMed 17907858Ghitza UE, Epstein DH, Preston KL. Psychosocial functioning and cocaine use during treatment: strength of relationship depends on type of urine-testing method. Drug Alcohol Depend. 2007 Dec 1;91(2-3):169-77. doi: 10.1016/j.drugalcdep.2007.05.018. Epub 2007 Jul 10.
PubMed 17624688Heinz A, Epstein DH, Preston KL. Spiritual/Religious experiences and in-treatment outcome in an inner-city program for heroin and cocaine dependence. J Psychoactive Drugs. 2007 Mar;39(1):41-9. doi: 10.1080/02791072.2007.10399863.
PubMed 17523584Heinz AJ, Epstein DH, Schroeder JR, Singleton EG, Heishman SJ, Preston KL. Heroin and cocaine craving and use during treatment: measurement validation and potential relationships. J Subst Abuse Treat. 2006 Dec;31(4):355-64. doi: 10.1016/j.jsat.2006.05.009. Epub 2006 Aug 1.
PubMed 17084789Ghitza UE, Epstein DH, Preston KL. Nonreporting of cannabis use: Predictors and relationship to treatment outcome in methadone maintained patients. Addict Behav. 2007 May;32(5):938-49. doi: 10.1016/j.addbeh.2006.06.034. Epub 2006 Aug 1.
PubMed 16887281
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
- Combined Behavioral and Pharmacologic Treatment of Polydrug Abuse
- ClinicalTrials.gov ID
- NCT00292123
- Acronym / sponsor ID
- NIDAIRP 326
- Conditions
- Opioid Dependence, Cocaine Abuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jun 1999
- Primary completion
- Jun 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 15 Feb 2006 (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 primary goal of this study is to determine how contingency management can best be combined with standard or high doses of methadone to increase simultaneous abstinence from heroin and cocaine.
Detailed description
A study of people pmaintained on Methadone using contingency management
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Opioid dependence; cocaine use
Key exclusion criteria (1 listed)
- Medical or psychiatric conditions that would contraindicate participation in a methadone maintenance study; inability to give informed consent; inability to attend clinic seven days a week
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 |
|---|---|---|
| Methadone | Drug | – |
| Contingency Management | Behavioural | – |
Primary outcome
Not reported in the source record.
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.
- Results publication: PubMed 18068905Ghitza UE, Epstein DH, Preston KL. Contingency management reduces injection-related HIV risk behaviors in heroin and cocaine using outpatients. Addict Behav. 2008 Apr;33(4):593-604. doi: 10.1016/j.addbeh.2007.11.009. Epub 2007 Nov 17.
- Results publication: PubMed 17931826Willner-Reid J, Belendiuk KA, Epstein DH, Schmittner J, Preston KL. Hepatitis C and human immunodeficiency virus risk behaviors in polydrug users on methadone maintenance. J Subst Abuse Treat. 2008 Jul;35(1):78-86. doi: 10.1016/j.jsat.2007.08.011. Epub 2007 Oct 10.
- Results publication: PubMed 17907858Ghitza UE, Epstein DH, Schmittner J, Vahabzadeh M, Lin JL, Preston KL. Randomized trial of prize-based reinforcement density for simultaneous abstinence from cocaine and heroin. J Consult Clin Psychol. 2007 Oct;75(5):765-74. doi: 10.1037/0022-006X.75.5.765.
- Results publication: PubMed 17624688Ghitza UE, Epstein DH, Preston KL. Psychosocial functioning and cocaine use during treatment: strength of relationship depends on type of urine-testing method. Drug Alcohol Depend. 2007 Dec 1;91(2-3):169-77. doi: 10.1016/j.drugalcdep.2007.05.018. Epub 2007 Jul 10.
- Results publication: PubMed 17523584Heinz A, Epstein DH, Preston KL. Spiritual/Religious experiences and in-treatment outcome in an inner-city program for heroin and cocaine dependence. J Psychoactive Drugs. 2007 Mar;39(1):41-9. doi: 10.1080/02791072.2007.10399863.
- Results publication: PubMed 17084789Heinz AJ, Epstein DH, Schroeder JR, Singleton EG, Heishman SJ, Preston KL. Heroin and cocaine craving and use during treatment: measurement validation and potential relationships. J Subst Abuse Treat. 2006 Dec;31(4):355-64. doi: 10.1016/j.jsat.2006.05.009. Epub 2006 Aug 1.
- Results publication: PubMed 16887281Ghitza UE, Epstein DH, Preston KL. Nonreporting of cannabis use: Predictors and relationship to treatment outcome in methadone maintained patients. Addict Behav. 2007 May;32(5):938-49. doi: 10.1016/j.addbeh.2006.06.034. Epub 2006 Aug 1.
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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.
Kenzie Preston, PhD principal investigator
NIFA Intramural Research Program
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methadone and Contingency Management in people with Opioid Dependence and Cocaine Abuse, run by National Institute on Drug Abuse (NIDA).
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 1 inclusion and 1 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.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00292123, which also lists 7 linked publications.
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.