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Adult Opioid-DependenceNCT00182598

Applying Web Technology to Buprenorphine Treatment

A study testing computer-based psychoeducational intervention and community-based substance abuse counseling in people with Adult Opioid-Dependence, run by National Development and Research Institutes, Inc. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this clinical trial is to examine the efficacy and cost-effectiveness of an interactive, computer-based psychoeducational system when used by opioid-dependent patients in office-based buprenorphine treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Opioid-Dependence
What is being tested?
computer-based psychoeducational intervention and community-based substance abuse counseling
Type of treatment
Surgery or procedure
How many people
90 participants
Where
2 sitesUnited States
Study dates
Dec 2004to not given
Phase
Interventional
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
  • Adults ( >/= 18 years)
  • In first month of office-based buprenorphine maintenance treatment

Who cannot join

  • In buprenorphine-assisted taper

Trial locations and contacts

2 sites in 1 country.

Lisa Marsch, PhD contact

212-845-4655

marsch@ndri.org

Honoria Guarino, PhD contact

212-845-4540

guarino@ndri.org

United States2 sites, 2 recruiting
  • Dr. Steven Lee

    New York, New York, 10011

    Lisa Marsch, PhD, 212-845-4655, marsch@ndri.org

    Honoria Guarino, PhD, 212-845-4540, guarino@ndri.org

    Recruiting
  • Dr. Tania Taubes

    New York, New York, 10023

    Lisa Marsch, PhD, 212-845-4655, marsch@ndri.org

    Honoria Guarino, PhD, 212-845-4540, guarino@nri.org

    Recruiting

Other trials in United States

About this study

The purpose of this clinical trial is to examine the efficacy and cost-effectiveness of an interactive, computer-based psychoeducational system when used by opioid-dependent patients in office-based buprenorphine treatment.

Read the detailed description

The partial opioid agonist, buprenorphine, was recently approved by the FDA for the treatment of opioid-dependence and will be available via physician prescription, enabling a greatly needed expansion of access to opioid treatment services. However, physicians, because of considerable demands on their time, will likely be unable to provide or coordinate referral for opioid-dependent patients to receive supplemental educational interventions that are critical to the success of their treatment. To address this challenge, we are developing an interactive, web-based patient education system for opioid-dependent individuals in office-based buprenorphine treatment. In this system, we plan to provide patients with educational interventions of demonstrated efficacy (e.g., information about buprenorphine, HIV/AIDS education, relapse prevention skills training). In Phase I, we demonstrated the scientific, technical and commercial merit and feasibility of this web-based patient education system by developing several modules of the program as well as the appropriate technology for the program to be delivered in an office-based setting. We subsequently assessed these modules in the context of feedback sessions conducted with opioid-dependent individuals in a lab designed to mimic the technical constraints of a physician's office. Results demonstrated that this system represents a viable approach to patient education in office-based buprenorphine treatment. During Phase II, we plan to complete our research and development efforts on this project. We will complete all educational modules of the system. We will also develop a "customization program" that patients can use to help them identify the optimal order in which they may access the program modules while in treatment. Additionally, we will establish an electronic reporting system that will provide physicians prescribing buprenorphine with patient activity reports, enabling them to track and document patient progress through the system and ensure that patients are compliant with ancillary educational interventions. Additionally, we plan to conduct a randomized, controlled trial to evaluate the efficacy and cost-effectiveness of this patient education system delivered via the Internet compared to the delivery of patient educational services by community-based treatment facilities outside of the office-based setting. This system will provide patients, physicians and the larger community with assurance that patients in office-based buprenorphine treatment are receiving ancillary services along with their medication, thereby improving their likelihood for a successful treatment outcome.

Being tested
computer-based psychoeducational intervention, community-based substance abuse counseling
Keywords
buprenorphine, computer, treatment, opioid, heroin
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.

  • computer-based psychoeducational interventionProcedure or surgery

  • community-based substance abuse counselingProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. opiate use

Secondary outcomes (6)
  1. treatment retention

  2. other drug use

  3. HIV risk behavior

  4. opiate craving

  5. psychosocial status

  6. feedback on intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startDec 2004

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00182598
Sponsor's protocol ID
R42DA014727
Status last verified
Aug 2008
First submitted
10 Sep 2005
Last updated
13 Aug 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing computer-based psychoeducational intervention and community-based substance abuse counseling in people with Adult Opioid-Dependence, run by National Development and Research Institutes, Inc. 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 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: status not confirmed, as of the sponsor's last update on 13 Aug 2008. 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.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lisa Marsch, PhD (212-845-4655, marsch@ndri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

opiate use. 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 13 Aug 2008.

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