AddictionNCT00935103
The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug Abuser for Reducing High-risk Behavior
A study testing Psychoeducation in people with Addiction and Risk Reduction Behaviour, run by Iran University of Medical Sciences.
Trial summary
The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug abuser for reducing high-risk behavior Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Addiction, Risk Reduction Behaviour
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 2011
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age more than 18 years old Dependency to opioid drugs (Positive result of Urin addiction test)
Who cannot join
- suicide attempt not tendency for including to the study receiving treatment for addiction in recent months.
About this study
The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug abuser for reducing high-risk behavior
- Conditions
- Addiction, Risk Reduction Behaviour
- Being tested
- Psychoeducation
- Keywords
- Addiction, Psychoeducation, Risk reduction behaviour, Drop in center (DIC)
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation | Active comparator | Psycheducation Receives: Behavioral: Psychoeducation |
| Control | No intervention | The control group will not take any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV usage of opioid
The number of usage by interview
Measured: 12 months
Secondary outcomes (1)
Usage of condom and safety syringe
the number of usage by interview
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AddictionStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935103
- Sponsor's protocol ID
- 117
- Status last verified
- Jul 2009
- First submitted
- 7 Jul 2009
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug Abuser for Reducing High-risk Behavior
- ClinicalTrials.gov ID
- NCT00935103
- Acronym / sponsor ID
- 117
- Conditions
- Addiction, Risk Reduction Behaviour
- Keywords
- Addiction, Psychoeducation, Risk reduction behaviour, Drop in center (DIC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Iran University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 8 Jul 2009 (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 Effectiveness of Skill-Based HIV Psychoeducation in IV-Drug abuser for reducing high-risk behavior
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Active comparator | Behavioral: PsychoeducationPsycheducation |
| Control | No intervention | –The control group will not take any intervention |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age more than 18 years old Dependency to opioid drugs (Positive result of Urin addiction test)
Key exclusion criteria (1 listed)
- suicide attempt not tendency for including to the study receiving treatment for addiction in recent months.
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 |
|---|---|---|
| Psychoeducation | Behavioural | Psychoeducation |
Primary outcome
IV usage of opioid
Time frame: 12 months
The number of usage by interview
1 secondary outcome
Usage of condom and safety syringe
Time frame: 12 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 22 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Addiction and Risk Reduction Behaviour, run by Iran University of Medical Sciences.
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 22 Aug 2023. 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.
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?
IV usage of opioid (time frame: 12 months). 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 22 Aug 2023.