Substance Use DisorderNCT02173041
Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User
A study testing Prevention Awareness Groups (PAG) in people with Substance Use Disorder and Drug Dependence,, run by Macmillan Research Group UK at 1 site in India.
Trial summary
Substance Use Disorder has been showing a rising trend all over the world including India. The project tested whether a Integrated community wide effort of Prevention and Awareness Groups (PAG) to manage substance use would have a greater effect on treatment attendance and drug abstinence than a de-addiction program… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Use Disorder, Drug Dependence,, Alcohol Dependence
- What is being tested?
- Prevention Awareness Groups (PAG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2014to Apr 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suburban, rural Population
- Drug and/or alcohol dependency (DSM-IV substance use disorders criteria)
Who cannot join
- Did not consent to participate
- Planning to move or relocate
- Severe mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User: Results of the Randomized Controlled Trial
Substance Use Disorder has been showing a rising trend all over the world including India. The project tested whether a Integrated community wide effort of Prevention and Awareness Groups (PAG) to manage substance use would have a greater effect on treatment attendance and drug abstinence than a de-addiction program alone.
- Conditions
- Substance Use Disorder, Drug Dependence,, Alcohol Dependence
- Being tested
- Prevention Awareness Groups (PAG), Standard Care
- Keywords
- Prevention and Awareness Groups (PAG),, Substance Use Disorder,, Community based intervention
- Medical subject headings
- Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevention Awareness Groups (PAG)Other
Standard CareOther
| Study group | Role | What they receive |
|---|---|---|
| Standard Usual Care | Other | Community program which follows with referral services Receives: Other: Standard Care |
| Prevention Awareness Groups (PAG) | Experimental | Prevention Awareness Groups (PAG) is a community based integrated substance abuse prevention program targeting vulnerable populations. It comprises of community programs, physician led counseling followed by treatment follow up in community based clinic. Receives: Other: Prevention Awareness Groups (PAG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment attendance
Measured: Change from baseline to six month
Secondary outcomes (1)
Drug abstinence
Measured: Change from baseline to six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Macmillan Research Group UK
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute, Warwick Research Services
- Responsible party
- Sponsor
- Investigators
- Valerie Murray, MA, Study director, Goldington Family CentreNeha Sharma, PhD, Principal investigator, NMP Medical Research InstituteAmit Punia, LLB, Study chair, NMP Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173041
- Sponsor's protocol ID
- Mac/NMP 1216
- Status last verified
- May 2015
- First submitted
- 22 Jun 2014
- Last updated
- 18 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Prevention Awareness Group (PAG) on Treatment Attendance and Drug Abstinence Among Substance User: Results of the Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02173041
- Acronym / sponsor ID
- Mac/NMP 1216
- Conditions
- Substance Use Disorder, Drug Dependence,, Alcohol Dependence
- Keywords
- Prevention and Awareness Groups (PAG),, Substance Use Disorder,, Community based intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Macmillan Research Group UKIndustry (pharma, biotech, devices)
- Collaborators
- NMP Medical Research Institute, Warwick Research Services
- Study start
- Aug 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Jun 2014 (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.
Substance Use Disorder has been showing a rising trend all over the world including India. The project tested whether a Integrated community wide effort of Prevention and Awareness Groups (PAG) to manage substance use would have a greater effect on treatment attendance and drug abstinence than a de-addiction program alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Usual Care | Other | Other: Standard CareCommunity program which follows with referral services |
| Prevention Awareness Groups (PAG) | Experimental | Other: Prevention Awareness Groups (PAG)Prevention Awareness Groups (PAG) is a community based integrated substance abuse prevention program targeting vulnerable populations. It comprises of community programs, physician led counseling followed by treatment follow up in community based clinic. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suburban, rural Population
- Drug and/or alcohol dependency (DSM-IV substance use disorders criteria)
Key exclusion criteria (3 listed)
- Did not consent to participate
- Planning to move or relocate
- Severe mental disorder
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 |
|---|---|---|
| Prevention Awareness Groups (PAG) | Other | Prevention Awareness Groups (PAG) |
| Standard Care | Other | Standard Usual Care |
Primary outcome
Treatment attendance
Time frame: Change from baseline to six month
1 secondary outcome
Drug abstinence
Time frame: Change from baseline to six month
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 18 May 2015.
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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.
Valerie Murray, MA study director
Goldington Family Centre
Neha Sharma, PhD principal investigator
NMP Medical Research Institute
Amit Punia, LLB study chair
NMP Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prevention Awareness Groups (PAG) in people with Substance Use Disorder and Drug Dependence,, run by Macmillan Research Group UK at 1 site in India.
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 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 18 May 2015. 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 India. 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?
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?
Treatment attendance (time frame: Change from baseline to six month). 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 18 May 2015.