Opiate DependencePhase 2NCT00406484
Brief Introductory Therapy for Opioid Dependence
A Phase 2 study testing Standard drug counseling and BDRC in people with Opiate Dependence and HIV Infections, run by Yale University at 2 sites in United States.
Trial summary
A randomized clinical trial to compare the efficacy of Behavioral Drug and HIV Risk Reduction Counseling (BDRC) and standard methadone drug counseling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Dependence, HIV Infections
- What is being tested?
- Standard drug counseling and BDRC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2004to Sep 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- opioid dependence
Who cannot join
- suicide or homicide risk
- psychiatric disorder requiring medication treatment
- life threatening or unstable medical problems
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Methadone Research Unit, The APT Foundation, Inc.
New Haven, Connecticut, 06519
Yale University School of Medicine
New Haven, Connecticut, 06519
About this study
A randomized clinical trial to compare the efficacy of Behavioral Drug and HIV Risk Reduction Counseling (BDRC) and standard methadone drug counseling.
Read the detailed description
The proposed study plans to compare the efficacy of behavioral drug and HIV risk reduction counseling (BDRC) to low intensity methadone counseling during methadone maintenance treatment. In selecting BDRC, we were guided by several considerations, including its acceptability, suitability, feasibility, potential efficacy, and potential for rapid and widespread dissemination in the U.S. and elsewhere. BDRC was developed to be delivered by regular drug counselors, so that it would be relatively easy to disseminate this counseling if it is found efficacious. BDRC combines behavioral contracting with an Information-Motivation-Behavioral Skills (IMB) model for reducing HIV risk behaviors and illicit drug use that is grounded in social cognitive theory and supported by empirical findings in a number of studies and populations. The more intensive HIV risk reduction interventions provided in BDRC, including personalized assessment of risk (i.e., identification of personal, social and environmental factors associated with risky behaviors) and education and training in skill-building and self-control, may lead to greater reductions in both drug- and sex-related HIV risk behaviors than the more limited, brief counseling provided in LIMC, as supported by findings of a recent clinical trial with methadone maintained patients and a meta-analysis regarding the effectiveness of HIV risk reduction interventions during drug abuse treatment. BDRC emphasizes a medical model of treatment for drug dependence and is highly complementary to and compatible with regular methadone maintenance treatment.
Because early abstinence achievement is associated with longer term treatment success, BDRC uses short-term behavioral contracts to help the patient achieve an initial period of abstinence, take maintenance medications regularly and as prescribed, activate the patient behaviorally, and reduce behaviors associated with HIV transmission. The accomplishment of specific, short-term behavioral goals early in treatment promotes the patient's experience of therapeutic success and counters the patient's belief that his/her actions will not lead to success in accomplishing goals. Short-term behavioral goals target a limited number of domains, including achieving an initial period of abstinence, increasing activities (primarily vocational, social or recreational) that are not related to drug use, and reducing HIV risk behaviors (e.g., fostering consistent condom use, avoiding casual sexual encounters, avoiding IDU or needle or equipment sharing). BDRC teaches cognitive and behavioral strategies for promoting behavioral change, including identifying antecedents of drug use, needle sharing, and high risk sexual behaviors, and learning strategies to avoid high risk situations or cope without engaging in these behaviors. Skill building exercises (e.g., regarding condom use) are used within sessions to learn and practice new skills, and patients are encouraged to practice these skills outside the session in their natural environment. Based on recent findings from research in cognitive and social psychology on message framing, the treatment also emphasizes the positive consequences of behavioral change (e.g., the benefits of not using drugs or of maintaining a steady relationship vs. the dangers associated with continued use or sex with multiple partners). Counselors are trained to acknowledge the patient's efforts to change-even partial accomplishments of goals are praised--rather than to focus on the patient's failures, which is often perceived as criticism. Recognition of accomplishments and positively framed messages generally evoke positive affect, which is often generalized and ascribed to the behavior in question, thus resulting in greater adherence to recommendations. An emphasis on recognition of accomplishments and positively-framed advice helps patients to build self-esteem and the sense that they can change their lives for the better.
Substance abuse is thought to be associated with a range of memory and executive function (EFs) deficits, but the majority of research support for this hypothesis comes from research on alcohol and stimulant related disorders. The evidence of long-term cognitive deficits in chronic opiate users is limited, nonetheless most consistently it suggests that EFs may be affected by chronic opiate use. Because BDRC incorporates many cognitive behavioral therapeutic techniques, includes educational and learning components and aims at improving decision making skills of the patients, we plan to evaluate a broad range of memory and executive functions of patients enrolled in the proposed study in order to identify common EFs impairments, evaluate if such impairments interfere with treatment efficacy, and if additional treatment components are necessary and can be devised in order to improve treatment efficacy for patients with cognitive impairments. We also plan to evaluate if cognitive performance improves during methadone maintenance treatment when combined with BDRC and evaluate whether presence or absence of impairments are associated with differential effects of treatments.
- Conditions
- Opiate Dependence, HIV Infections
- Being tested
- Standard drug counseling, BDRC
- Keywords
- Methadone, Counseling, HIV risk reduction, HIV Seronegativity
- Medical subject headings
- Opioid-Related Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard drug counselingBehavioural
Individual drug counseling
BDRCBehavioural
Behavioral Drug and HIV Risk Reduction Counseling, individual once or twice weekly sessions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral Drug and HIV Risk Reduction Counseling (BDRC) Receives: Behavioral: BDRC |
| 2 | Active comparator | Standard drug counseling Receives: Behavioral: Standard drug counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum number of consecutive weeks of opiate abstinence achieved during treatment
Measured: 12 weeks
Overall proportion of opiate negative urines tests in each treatment group
Measured: 12 weeks
Reduction in HIV risk behaviors
Measured: 12 weeks
Secondary outcomes (1)
Improvements in social, employment, legal, medical and psychiatric functioning
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 Dec 2006 (estimated)
- Study startSep 2004
- Primary completionSep 2009
- Study completionSep 2010
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 51 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
- Marek C Chawarski, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00406484
- Sponsor's protocol ID
- 0607001647
- Other IDs
- 2R01DA013108-04
- Status last verified
- Mar 2020
- First submitted
- 30 Nov 2006
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Introductory Therapy for Opioid Dependence
- ClinicalTrials.gov ID
- NCT00406484
- Acronym / sponsor ID
- 0607001647
- Conditions
- Opiate Dependence, HIV Infections
- Keywords
- Methadone, Counseling, HIV risk reduction, HIV Seronegativity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2004
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Dec 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.
A randomized clinical trial to compare the efficacy of Behavioral Drug and HIV Risk Reduction Counseling (BDRC) and standard methadone drug counseling.
Detailed description
The proposed study plans to compare the efficacy of behavioral drug and HIV risk reduction counseling (BDRC) to low intensity methadone counseling during methadone maintenance treatment. In selecting BDRC, we were guided by several considerations, including its acceptability, suitability, feasibility, potential efficacy, and potential for rapid and widespread dissemination in the U.S. and elsewhere. BDRC was developed to be delivered by regular drug counselors, so that it would be relatively easy to disseminate this counseling if it is found efficacious. BDRC combines behavioral contracting with an Information-Motivation-Behavioral Skills (IMB) model for reducing HIV risk behaviors and illicit drug use that is grounded in social cognitive theory and supported by empirical findings in a number of studies and populations. The more intensive HIV risk reduction interventions provided in BDRC, including personalized assessment of risk (i.e., identification of personal, social and environmental factors associated with risky behaviors) and education and training in skill-building and self-control, may lead to greater reductions in both drug- and sex-related HIV risk behaviors than the more limited, brief counseling provided in LIMC, as supported by findings of a recent clinical trial with methadone maintained patients and a meta-analysis regarding the effectiveness of HIV risk reduction interventions during drug abuse treatment. BDRC emphasizes a medical model of treatment for drug dependence and is highly complementary to and compatible with regular methadone maintenance treatment.
Because early abstinence achievement is associated with longer term treatment success, BDRC uses short-term behavioral contracts to help the patient achieve an initial period of abstinence, take maintenance medications regularly and as prescribed, activate the patient behaviorally, and reduce behaviors associated with HIV transmission. The accomplishment of specific, short-term behavioral goals early in treatment promotes the patient's experience of therapeutic success and counters the patient's belief that his/her actions will not lead to success in accomplishing goals. Short-term behavioral goals target a limited number of domains, including achieving an initial period of abstinence, increasing activities (primarily vocational, social or recreational) that are not related to drug use, and reducing HIV risk behaviors (e.g., fostering consistent condom use, avoiding casual sexual encounters, avoiding IDU or needle or equipment sharing). BDRC teaches cognitive and behavioral strategies for promoting behavioral change, including identifying antecedents of drug use, needle sharing, and high risk sexual behaviors, and learning strategies to avoid high risk situations or cope without engaging in these behaviors. Skill building exercises (e.g., regarding condom use) are used within sessions to learn and practice new skills, and patients are encouraged to practice these skills outside the session in their natural environment. Based on recent findings from research in cognitive and social psychology on message framing, the treatment also emphasizes the positive consequences of behavioral change (e.g., the benefits of not using drugs or of maintaining a steady relationship vs. the dangers associated with continued use or sex with multiple partners). Counselors are trained to acknowledge the patient's efforts to change-even partial accomplishments of goals are praised--rather than to focus on the patient's failures, which is often perceived as criticism. Recognition of accomplishments and positively framed messages generally evoke positive affect, which is often generalized and ascribed to the behavior in question, thus resulting in greater adherence to recommendations. An emphasis on recognition of accomplishments and positively-framed advice helps patients to build self-esteem and the sense that they can change their lives for the better.
Substance abuse is thought to be associated with a range of memory and executive function (EFs) deficits, but the majority of research support for this hypothesis comes from research on alcohol and stimulant related disorders. The evidence of long-term cognitive deficits in chronic opiate users is limited, nonetheless most consistently it suggests that EFs may be affected by chronic opiate use. Because BDRC incorporates many cognitive behavioral therapeutic techniques, includes educational and learning components and aims at improving decision making skills of the patients, we plan to evaluate a broad range of memory and executive functions of patients enrolled in the proposed study in order to identify common EFs impairments, evaluate if such impairments interfere with treatment efficacy, and if additional treatment components are necessary and can be devised in order to improve treatment efficacy for patients with cognitive impairments. We also plan to evaluate if cognitive performance improves during methadone maintenance treatment when combined with BDRC and evaluate whether presence or absence of impairments are associated with differential effects of treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: BDRCBehavioral Drug and HIV Risk Reduction Counseling (BDRC) |
| 2 | Active comparator | Behavioral: Standard drug counselingStandard drug counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- opioid dependence
Key exclusion criteria (3 listed)
- suicide or homicide risk
- psychiatric disorder requiring medication treatment
- life threatening or unstable medical 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 |
|---|---|---|
| Standard drug counselingIndividual drug counseling | Behavioural | 2 |
| BDRCBehavioral Drug and HIV Risk Reduction Counseling, individual once or twice weekly sessions | Behavioural | 1 |
Primary outcome
Maximum number of consecutive weeks of opiate abstinence achieved during treatment
Time frame: 12 weeks
Overall proportion of opiate negative urines tests in each treatment group
Time frame: 12 weeks
Reduction in HIV risk behaviors
Time frame: 12 weeks
1 secondary outcome
Improvements in social, employment, legal, medical and psychiatric functioning
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 2 Apr 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.
Marek C Chawarski, Ph.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 Standard drug counseling and BDRC in people with Opiate Dependence and HIV Infections, 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 1 inclusion and 3 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 2 Apr 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. 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?
Maximum number of consecutive weeks of opiate abstinence achieved during treatment (time frame: 12 weeks). 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 2 Apr 2020.