Opiate DependencePhase 3NCT01389180
Behavioral Drug and HIV Risk Reduction Counseling With MMT in China
A Phase 3 study testing Behavioral Drug and HIV Risk Reduction Counseling, Educational Counseling and Treatment as Usual in people with Opiate Dependence, run by Yale University at 1 site in China.
Trial summary
This study will provide critical data regarding the efficacy for reducing drug-and sex-related HIV transmission risk behaviors, as well as improving methadone maintenance treatment (MMT) outcomes and patient functioning of two transportable counseling models, behavioral drug and HIV risk reduction counseling (BDRC)… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Opiate Dependence
- What is being tested?
- Behavioral Drug and HIV Risk Reduction Counseling, Educational Counseling and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Jun 2016
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- treatment seeking volunteers meeting DSM-IV criteria for opiate dependence, as assessed by SCID interview and documented by opioid positive urine toxicology testing, entering MMT in Wuhan. China
Who cannot join
- current dependence on alcohol, benzodiazepines or sedatives
- current suicide or homicide risk
- current psychotic disorder or major depression
- inability to understand the protocol or assessment questions
Trial locations and contacts
1 site in 1 country.
About this study
This study will provide critical data regarding the efficacy for reducing drug-and sex-related HIV transmission risk behaviors, as well as improving methadone maintenance treatment (MMT) outcomes and patient functioning of two transportable counseling models, behavioral drug and HIV risk reduction counseling (BDRC) and educational counseling (EC) as compared with the current standard of care model in MMT in China. Evidence-based counseling that is efficacious in reducing HIV risks and drug use and is feasible to provide with MMT will greatly improve the public health benefits of disseminating MMT in China and elsewhere in the world.
Read the detailed description
China currently has 1.2 to 3.5 million heroin users (50% with current injection drug use, IDU), and more than 650,000 HIV infected individuals, with 75,000 new infections each year and the majority of HIV infections attributable to IDU. The Chinese government recently embarked on an ambitious program to make methadone maintenance treatment (MMT) widely available to all heroin addicts. By the end of 2008, approximately 560 methadone maintenance treatment clinics had been established, providing treatment to an estimated 166,000 heroin users. However, the current methadone programs provide limited or no drug counseling, and, despite considerable initial promise, many patients continue drug use and risky behaviors while still in MMT or discontinue treatment prematurely. In addition to risky injecting practices, drug users in China also commonly engage in risky sexual practices. Most of China's drug users are young, unmarried, sexually active and only a small fraction report consistent condom use. Their knowledge about HIV/AIDS, sexually transmitted diseases and blood borne viruses is very poor. The combination of poor knowledge and frequent engagement in high-risk behaviors increases their own risk of infections, and also contributes significantly to the spread of HIV into the general population. [Consequently, we propose a randomized clinical trial to compare the efficacy of MMT combined with one of three manual-guided counseling approaches, Behavioral Drug and HIV Risk Reduction Counseling (BDRC), Educational Counseling (EC), and counseling approximating what is provided as treatment as usual (TAU) in China. Efficacy will be evaluated with regard to our primary outcome measures: reduction of drug- and sex-related HIV risk behaviors, reduction of frequency of heroin or other illicit opiate use, and duration of opiate abstinence. The study will also evaluate treatment effects on secondary outcome measures (including treatment retention, reductions in other illicit drug use, and improvements of functional status of MMT patients) and incremental resource utilization associated with BDRC, EC and TAU. In preliminary work, we have developed and pilot tested Mandarin versions of the BDRC manual, BDRC and EC training materials, and assessment instruments. Treatment seeking volunteers(N=300) entering MMT will be randomly assigned to 4 months of treatment with one of the three manual-guided treatments. A standard methadone induction and dosing protocol will be used for all subjects to ensure comparable methadone dosages in all groups. All primary and secondary outcome measures will be evaluated during the 4 months of MMT treatment phase and for 6 months following the active treatment phase.
- Conditions
- Opiate Dependence
- Being tested
- Behavioral Drug and HIV Risk Reduction Counseling, Educational Counseling, Treatment as Usual
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Drug and HIV Risk Reduction CounselingBehavioural
BDRC is a highly individualized, structured, and prescriptive behavioral treatment designed to be provided by nursing or other available personnel in China who generally do not have advanced training or experience in psychotherapy or counseling techniques. BDRC provides education about HIV, Hepatitis C, and other bloodborne or infectious diseases, heroin addiction and MMT, incorporates coping skills training components of CBT, and makes use of explicit and detailed short-term behavioral contracts (either verbal or written), aimed at small, easily achievable, and measurable objectives linked to reduction of HIV risk behaviors and heroin use and improvements in daily functioning supporting sustained recovery
Educational CounselingBehavioural
EC uses a didactic lecture-discussion format, incorporating charts, slides, and audiovisual materials and handouts, to educate the patient about core recovery topics, including HIV and other infectious diseases transmission and effective protection strategies, heroin addiction and treatment with methadone maintenance, the importance of taking the methadone regularly, staying away from drugs, and improving social, family and vocational functioning.
Treatment as UsualBehavioural
TAU group will receive manual-guided minimal counseling approximating the current standard of care provided in MMTs in China, consisting of an initial introductory session (introduction to MMT and basic education about HIV risks) and subsequent, brief (up to 20 minutes) support and advice sessions once per month
| Study group | Role | What they receive |
|---|---|---|
| BDRC | Experimental | Not described Receives: Behavioral: Behavioral Drug and HIV Risk Reduction Counseling |
| EC | Experimental | Not described Receives: Behavioral: Educational Counseling |
| TAU | Other | Not described Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of drug- and sex-related HIV risk behaviors
drug-related and sex-related HIV risk behaviors will be assessed by audio computer-assisted self-interview
Measured: Up to 10 months
Reduction of frequency (days of illicit opiate use in each month) of heroin or other illicit opiate use
days of illicit opiate use in each month will be based on self report and urine toxicology tests
Measured: Up to 10 months
Secondary outcomes (3)
Treatment retention
Treatment retention is defined as time in treatment from the treatment entry to treatment completion or discontinuation
Measured: at 16 weeks
Reductions in other illicit drug use
Reductions in other illicit drug use are based on self-report and urine toxicology screens
Measured: Up to 10 months
Improvements of functional status (e.g., in vocational, family, and social functioning, and healthcare and other resource utilization)
Improvements of functional status are based on the results of Addiction Severity Index assessment instrument
Measured: Up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startDec 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opiate 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Wang Zhou, M.D., Ph.D., Principal investigator, Center for Disease Control & Prevention, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389180
- Sponsor's protocol ID
- 0907005504
- Other IDs
- R01DA026797-01A1
- Status last verified
- Mar 2020
- First submitted
- 11 May 2011
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Drug and HIV Risk Reduction Counseling With MMT in China
- ClinicalTrials.gov ID
- NCT01389180
- Acronym / sponsor ID
- 0907005504
- Conditions
- Opiate Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, China, National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Jul 2011 (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.
This study will provide critical data regarding the efficacy for reducing drug-and sex-related HIV transmission risk behaviors, as well as improving methadone maintenance treatment (MMT) outcomes and patient functioning of two transportable counseling models, behavioral drug and HIV risk reduction counseling (BDRC) and educational counseling (EC) as compared with the current standard of care model in MMT in China. Evidence-based counseling that is efficacious in reducing HIV risks and drug use and is feasible to provide with MMT will greatly improve the public health benefits of disseminating MMT in China and elsewhere in the world.
Detailed description
China currently has 1.2 to 3.5 million heroin users (50% with current injection drug use, IDU), and more than 650,000 HIV infected individuals, with 75,000 new infections each year and the majority of HIV infections attributable to IDU. The Chinese government recently embarked on an ambitious program to make methadone maintenance treatment (MMT) widely available to all heroin addicts. By the end of 2008, approximately 560 methadone maintenance treatment clinics had been established, providing treatment to an estimated 166,000 heroin users. However, the current methadone programs provide limited or no drug counseling, and, despite considerable initial promise, many patients continue drug use and risky behaviors while still in MMT or discontinue treatment prematurely. In addition to risky injecting practices, drug users in China also commonly engage in risky sexual practices. Most of China's drug users are young, unmarried, sexually active and only a small fraction report consistent condom use. Their knowledge about HIV/AIDS, sexually transmitted diseases and blood borne viruses is very poor. The combination of poor knowledge and frequent engagement in high-risk behaviors increases their own risk of infections, and also contributes significantly to the spread of HIV into the general population. [Consequently, we propose a randomized clinical trial to compare the efficacy of MMT combined with one of three manual-guided counseling approaches, Behavioral Drug and HIV Risk Reduction Counseling (BDRC), Educational Counseling (EC), and counseling approximating what is provided as treatment as usual (TAU) in China. Efficacy will be evaluated with regard to our primary outcome measures: reduction of drug- and sex-related HIV risk behaviors, reduction of frequency of heroin or other illicit opiate use, and duration of opiate abstinence. The study will also evaluate treatment effects on secondary outcome measures (including treatment retention, reductions in other illicit drug use, and improvements of functional status of MMT patients) and incremental resource utilization associated with BDRC, EC and TAU. In preliminary work, we have developed and pilot tested Mandarin versions of the BDRC manual, BDRC and EC training materials, and assessment instruments. Treatment seeking volunteers(N=300) entering MMT will be randomly assigned to 4 months of treatment with one of the three manual-guided treatments. A standard methadone induction and dosing protocol will be used for all subjects to ensure comparable methadone dosages in all groups. All primary and secondary outcome measures will be evaluated during the 4 months of MMT treatment phase and for 6 months following the active treatment phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BDRC | Experimental | Behavioral: Behavioral Drug and HIV Risk Reduction Counseling |
| EC | Experimental | Behavioral: Educational Counseling |
| TAU | Other | Behavioral: Treatment as Usual |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- treatment seeking volunteers meeting DSM-IV criteria for opiate dependence, as assessed by SCID interview and documented by opioid positive urine toxicology testing, entering MMT in Wuhan. China
Key exclusion criteria (4 listed)
- current dependence on alcohol, benzodiazepines or sedatives
- current suicide or homicide risk
- current psychotic disorder or major depression
- inability to understand the protocol or assessment questions
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 |
|---|---|---|
| Behavioral Drug and HIV Risk Reduction CounselingBDRC is a highly individualized, structured, and prescriptive behavioral treatment designed to be provided by nursing or other available personnel in China who generally do not have advanced training or experience in psychotherapy or counseling techniques. BDRC provides education about HIV, Hepatitis C, and other bloodborne or infectious diseases, heroin addiction and MMT, incorporates coping skills training components of CBT, and makes use of explicit and detailed short-term behavioral contracts (either verbal or written), aimed at small, easily achievable, and measurable objectives linked to reduction of HIV risk behaviors and heroin use and improvements in daily functioning supporting sustained recovery | Behavioural | BDRC |
| Educational CounselingEC uses a didactic lecture-discussion format, incorporating charts, slides, and audiovisual materials and handouts, to educate the patient about core recovery topics, including HIV and other infectious diseases transmission and effective protection strategies, heroin addiction and treatment with methadone maintenance, the importance of taking the methadone regularly, staying away from drugs, and improving social, family and vocational functioning. | Behavioural | EC |
| Treatment as UsualTAU group will receive manual-guided minimal counseling approximating the current standard of care provided in MMTs in China, consisting of an initial introductory session (introduction to MMT and basic education about HIV risks) and subsequent, brief (up to 20 minutes) support and advice sessions once per month | Behavioural | TAU |
Primary outcome
Reduction of drug- and sex-related HIV risk behaviors
Time frame: Up to 10 months
drug-related and sex-related HIV risk behaviors will be assessed by audio computer-assisted self-interview
Reduction of frequency (days of illicit opiate use in each month) of heroin or other illicit opiate use
Time frame: Up to 10 months
days of illicit opiate use in each month will be based on self report and urine toxicology tests
3 secondary outcomes
Treatment retention
Time frame: at 16 weeks
Reductions in other illicit drug use
Time frame: Up to 10 months
Improvements of functional status (e.g., in vocational, family, and social functioning, and healthcare and other resource utilization)
Time frame: Up to 10 months
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 6 Mar 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.
Wang Zhou, M.D., Ph.D. principal investigator
Center for Disease Control & Prevention, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Behavioral Drug and HIV Risk Reduction Counseling, Educational Counseling and Treatment as Usual in people with Opiate Dependence, run by Yale University at 1 site in China.
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 4 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 6 Mar 2020. 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 China. 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?
Reduction of drug- and sex-related HIV risk behaviors (time frame: Up to 10 months). 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 6 Mar 2020.