Substance-Related DisordersPhase 3NCT00033020
Motivational Incentives for Enhanced Drug Abuse Recovery: Methadone Clinics. - 1
A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by Johns Hopkins University at 7 sites in United States.
Trial summary
The purpose of this study is to test the utilization of incentive values (considerably lower than those typically used in research clinics) to motivate clients to attend treatment and initiate and sustain abstinence. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 390 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2001to Feb 2003
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recent admission to an opioid substitution (methadone maintenance) CTP. Completed at least 4 weeks of maintenance at time of study entry
- Evidence of cocaine or methamphetamine use Minimum of one documented positive urine within 2 weeks of study entry. For those exiting a controlled environment, any stimulant use within two weeks of entering the controlled environment
Who cannot join
- Unable to give informed consent (fails simple consent quiz)
- Answers yes to question: Are you in recovery from gambling? That is, have you stopped gambling because of previous gambling problems?
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Aegis Medical Systems, Inc.
Bakersfield, California, 93301 4709
Glenwood Life Counseling Center
Baltimore, Maryland, 21212
Charleston Center
Charleston, South Carolina, 29403
Lower Eastside Service Center (LESC)
New York, New York, 10007
Greenwich House, Inc.
New York, New York, 10014
ACT
Philadelphia, Pennsylvania, 19141
Oasis Clinic
Washington D.C., District of Columbia, 20002
About this study
Official title: Motivational Incentives for Enhanced Drug Abuse Recovery: Methadone Clinics
The purpose of this study is to test the utilization of incentive values (considerably lower than those typically used in research clinics) to motivate clients to attend treatment and initiate and sustain abstinence.
Read the detailed description
The purpose of the proposed research is to implement and systematically evaluate, in community treatment settings, motivational incentive procedures that have been well researched and have proven efficacious in a variety of treatment research clinics. The study will determine if motivational incentives along with standard care therapy is more effective than standard therapy alone for the treatment of patients using cocaine or methamphetamine and entering a substance abuse treatment program.
- Conditions
- Substance-Related Disorders
- Being tested
- Behavior Therapy
- Keywords
- substance use disorders
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
ASI
Opioid and cocaine use
AIDS risk behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2002 (estimated)
- Study startApr 2001
- Primary completionFeb 2003
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 390 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Investigators
- Maxine Stitzer, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033020
- Sponsor's protocol ID
- NIDA-CTN-0007-1
- Status last verified
- Apr 2010
- First submitted
- 5 Apr 2002
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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
- Motivational Incentives for Enhanced Drug Abuse Recovery: Methadone Clinics
- ClinicalTrials.gov ID
- NCT00033020
- Acronym / sponsor ID
- NIDA-CTN-0007-1
- Conditions
- Substance-Related Disorders
- Keywords
- substance use disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2001
- Primary completion
- Feb 2003 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 8 Apr 2002 (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 purpose of this study is to test the utilization of incentive values (considerably lower than those typically used in research clinics) to motivate clients to attend treatment and initiate and sustain abstinence.
Detailed description
The purpose of the proposed research is to implement and systematically evaluate, in community treatment settings, motivational incentive procedures that have been well researched and have proven efficacious in a variety of treatment research clinics. The study will determine if motivational incentives along with standard care therapy is more effective than standard therapy alone for the treatment of patients using cocaine or methamphetamine and entering a substance abuse treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Recent admission to an opioid substitution (methadone maintenance) CTP. Completed at least 4 weeks of maintenance at time of study entry
- Evidence of cocaine or methamphetamine use Minimum of one documented positive urine within 2 weeks of study entry. For those exiting a controlled environment, any stimulant use within two weeks of entering the controlled environment
Key exclusion criteria (2 listed)
- Unable to give informed consent (fails simple consent quiz)
- Answers yes to question: Are you in recovery from gambling? That is, have you stopped gambling because of previous gambling problems?
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 |
|---|---|---|
| Behavior Therapy | Behavioural | – |
Primary outcome
ASI
Opioid and cocaine use
AIDS risk behavior
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.
- Data ElementsLink provided by the sponsor.
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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.
Maxine Stitzer, Ph.D. principal investigator
Johns Hopkins University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavior Therapy in people with Substance-Related Disorders, run by Johns Hopkins University at 7 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 2 inclusion and 2 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 7 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
ASI. The study lists 3 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.