Drug UsagePhase 3ASPIRENCT00876941
Assessing Screening Plus Brief Intervention's Resulting Efficacy (ASPIRE) to Stop Drug Use
A Phase 3 study testing Standard Brief Intervention and Enhanced Brief Intervention in people with Drug Usage and Drug Abuse, run by Boston Medical Center at 1 site in United States.
Trial summary
The objective of this study is to test whether screening and brief intervention for drug use among primary care patients leads to improved drug-related outcomes (such as decreased drug use and consequences). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Usage, Drug Abuse, Drug Dependence
- What is being tested?
- Standard Brief Intervention and Enhanced Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 589 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Arrived for a visit in primary care
- ASSIST Substance Specific Involvement Score of greater than or equal to 4 for subjects included in primary analyses; ASSIST Substance-Specific Involvement Scores of 2 or 3 for subjects included only in exploratory analyses
- No previous MASBIRT intervention in the past 3 months
- Fluent in English or Spanish
- Two contacts who can assist with locating the subject for follow-up
Show all 9Show fewer
- Able to return to Boston Medical Center in the next 6 months for research study visits
- Not pregnant (because care systems and resources differ greatly for such subjects)
- Able to be interviewed by trained research staff (excluding those in acute discomfort or with significantly impaired cognition)
Who cannot join
- NOT 18 years of age or older
- NOT Arrived for a visit in primary care
- NO ASSIST Substance Specific Involvement Score of greater than or equal to 4 for subjects included in primary analyses; or NO ASSIST Substance-Specific Involvement Scores of 2 or 3 for subjects included only in exploratory analyses
- ANY previous MASBIRT intervention in the past 3 months
- NOT Fluent in English or Spanish
- FEWER THAN two contacts who can assist with locating the subject for follow-up
Show all 9Show fewer
- NOT able to return to Boston Medical Center in the next 6 months for research study visits
- Pregnant (because care systems and resources differ greatly for such subjects)
- UN-Able to be interviewed by trained research staff (excluding those in acute discomfort or with significantly impaired cognition)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy/Effectiveness of Unhealthy Drug Use Screening/Brief Intervention Models
The objective of this study is to test whether screening and brief intervention for drug use among primary care patients leads to improved drug-related outcomes (such as decreased drug use and consequences).
Read the detailed description
The efficacy of screening and brief intervention (SBI) for drug use among primary care patients is unknown. National organizations do not recommend universal screening. But policy is at odds with the evidence: federal efforts to disseminate SBI are underway, and reimbursement codes to compensate clinicians have been developed. Thus there is a need to study SBI for drug use. The objective of this study is to determine the efficacy of two models of brief intervention (BI) for decreasing drug use and consequences in primary care patients. In collaboration with a state project implementing SBI as part of a federal program, we will screen patients in a large hospital-based primary care practice for drug use. We will then enroll screen-positive subjects, randomly assign them to 1 of 3 groups, and follow them for 6 months. Subjects in 1 intervention group will be assigned to a standard BI model, conducted by trained health advocates implementing a Federal program locally. In another group, subjects will be assigned to an enhanced BI model that includes an optional booster contact and is conducted by master's-level counselors trained and monitored intensively. The control group will receive information (i.e., a written list of local resources to help people using drugs) and, at the end of six months, standard BI if they are still using drugs.
All subjects will be assessed regarding substance use and consequences, HIV risk behaviors, costs, healthcare utilization and receipt of substance dependence treatment. The primary outcome is drug use at 6 months; secondary outcomes are drug use consequences, including HIV risk behaviors, and receipt of substance dependence treatment (among those with dependence). We hypothesize that the standard BI and the enhanced BI will each have greater efficacy than screening and resource information alone for decreasing drug use, decreasing drug use consequences and HIV risk behaviors and increasing receipt of treatment for those with dependence.
Additionally, costs will also be compared. Results of this study re: efficacy and costs of brief intervention for drug use will be essential for making decisions about disseminating drug use SBI in primary care settings.
This study will enroll two cohorts:
- We will enroll 450 subjects with an ASSIST Substance-Specific Involvement (SSI) Score of 4 or greater in order to test our primary hypotheses. Primary analyses (i.e., effect of each BI on unhealthy drug use) will be restricted to subjects with an ASSIST SSI Score of 4 or greater.
- We will enroll an additional 200 subjects with an ASSIST SSI Score of 2 or 3, indicating some, but lower risk drug use. Patients with these scores are included in clinical interventions, but because there are no data on effectiveness in the literature, this cohort will not be included in primary analyses and instead will be included only in secondary and exploratory analyses. We will examine potential preventive effects of BI (either) on subjects with lower level drug use.
- Conditions
- Drug Usage, Drug Abuse, Drug Dependence
- Being tested
- Standard Brief Intervention, Enhanced Brief Intervention, Control: Information and Feedback
- Keywords
- Drug, Drug Use, Screening, Brief Intervention, Primary Care, Utilization
- Medical subject headings
- Substance-Related Disorders, Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Brief InterventionBehavioural
Also called BI-S
Intervention: Structured, brief negotiated interview.
Intervention preparation and content: Preparation: review of ASSIST results; Content: The intervention involves 4 major parts: 1) establishing rapport and asking the subject for permission to raise the topic of drug use; 2) exploring the pros and cons of use; 3) providing feedback and assessing readiness to change; and 4) advising and negotiating a plan.
Counselor: Health Promotion Advocate, High School graduate or GED minimum Training specific to the brief intervention: Didactic and experiential; competency demonstrated by observation and/or video recordings which are content scored using a standardized form.
Contacts, Duration: One, 10-15 minutes.
Communication content delivered to primary care physician: Results of screening and BI.
Supervision: Weekly 1-hour meeting with supervisor to discuss job performance and discuss cases; biannual shadowing by supervisor.
Enhanced Brief InterventionBehavioural
Also called BI-E
Intervention: Less structured, motivational interview.
Intervention preparation and content: Preparation: review of ASSIST, drug consequences (SIP-D), risk behaviors, CIDI Short Form, and medical record for discussion; Content: Motivational interviewing discussing above.
Counselor: Master's level/Doctoral student.
Training specific to the brief intervention: Didactic and experiential, followed by additional work towards, and confirmation of, proficiency using audio recordings coded for motivational interviewing content.
Contacts, Duration: One plus offer of one optional booster contact, each 30-45 minutes; 2nd by telephone or in person depending on subject's preference; availability of counselor for further readiness discussions.
Communication content delivered to primary care physician: Results of screening, BI, and plan including follow-up.
Supervision: Weekly 1.5-hour meeting with supervisor with review of coded audio recordings.
Control: Information and FeedbackBehavioural
Subjects randomized to the control group will not receive a BI at enrollment. But, all study subjects will receive screening and its results as part of the informed consent process (that they are at least at risk for drug use health hazards) along with a written list of resources available, including local options.
| Study group | Role | What they receive |
|---|---|---|
| Standard Brief Intervention | Experimental | Not described Receives: Behavioral: Standard Brief Intervention |
| Enhanced Brief Intervention | Experimental | Not described Receives: Behavioral: Enhanced Brief Intervention |
| Control | Active comparator | Not described Receives: Behavioral: Control: Information and Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug use
Measured: Six Months
Secondary outcomes (4)
Drug use consequences
Measured: Six Months
HIV risk behaviors
Measured: Six Months
Substance abuse treatment utilization
Measured: Six Months
Costs
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2012
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Drug UsageStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 589 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Boston University, RTI International
- Responsible party
- Sponsor
- Investigators
- Richard Saitz, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876941
- Sponsor's protocol ID
- DESPR DA025068
- Other IDs
- R01DA025068, Grant Number: 1R01DA025068
- Acronym
- ASPIRE
- Status last verified
- Feb 2012
- First submitted
- 6 Apr 2009
- Last updated
- 2 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Alford DP, German JS, Samet JH, Cheng DM, Lloyd-Travaglini CA, Saitz R. Primary Care Patients with Drug Use Report Chronic Pain and Self-Medicate with Alcohol and Other Drugs. J Gen Intern Med. 2016 May;31(5):486-91. doi: 10.1007/s11606-016-3586-5. Epub 2016 Jan 25.
PubMed 26809204Saitz R, Palfai TP, Cheng DM, Alford DP, Bernstein JA, Lloyd-Travaglini CA, Meli SM, Chaisson CE, Samet JH. Screening and brief intervention for drug use in primary care: the ASPIRE randomized clinical trial. JAMA. 2014 Aug 6;312(5):502-13. doi: 10.1001/jama.2014.7862.
PubMed 25096690
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy/Effectiveness of Unhealthy Drug Use Screening/Brief Intervention Models
- ClinicalTrials.gov ID
- NCT00876941
- Acronym / sponsor ID
- ASPIRE / DESPR DA025068
- Conditions
- Drug Usage, Drug Abuse, Drug Dependence
- Keywords
- Drug, Drug Use, Screening, Brief Intervention, Primary Care, Utilization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 589 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Boston University, RTI International
- Study start
- Apr 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Apr 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 objective of this study is to test whether screening and brief intervention for drug use among primary care patients leads to improved drug-related outcomes (such as decreased drug use and consequences).
Detailed description
The efficacy of screening and brief intervention (SBI) for drug use among primary care patients is unknown. National organizations do not recommend universal screening. But policy is at odds with the evidence: federal efforts to disseminate SBI are underway, and reimbursement codes to compensate clinicians have been developed. Thus there is a need to study SBI for drug use. The objective of this study is to determine the efficacy of two models of brief intervention (BI) for decreasing drug use and consequences in primary care patients. In collaboration with a state project implementing SBI as part of a federal program, we will screen patients in a large hospital-based primary care practice for drug use. We will then enroll screen-positive subjects, randomly assign them to 1 of 3 groups, and follow them for 6 months. Subjects in 1 intervention group will be assigned to a standard BI model, conducted by trained health advocates implementing a Federal program locally. In another group, subjects will be assigned to an enhanced BI model that includes an optional booster contact and is conducted by master's-level counselors trained and monitored intensively. The control group will receive information (i.e., a written list of local resources to help people using drugs) and, at the end of six months, standard BI if they are still using drugs.
All subjects will be assessed regarding substance use and consequences, HIV risk behaviors, costs, healthcare utilization and receipt of substance dependence treatment. The primary outcome is drug use at 6 months; secondary outcomes are drug use consequences, including HIV risk behaviors, and receipt of substance dependence treatment (among those with dependence). We hypothesize that the standard BI and the enhanced BI will each have greater efficacy than screening and resource information alone for decreasing drug use, decreasing drug use consequences and HIV risk behaviors and increasing receipt of treatment for those with dependence.
Additionally, costs will also be compared. Results of this study re: efficacy and costs of brief intervention for drug use will be essential for making decisions about disseminating drug use SBI in primary care settings.
This study will enroll two cohorts:
- We will enroll 450 subjects with an ASSIST Substance-Specific Involvement (SSI) Score of 4 or greater in order to test our primary hypotheses. Primary analyses (i.e., effect of each BI on unhealthy drug use) will be restricted to subjects with an ASSIST SSI Score of 4 or greater.
- We will enroll an additional 200 subjects with an ASSIST SSI Score of 2 or 3, indicating some, but lower risk drug use. Patients with these scores are included in clinical interventions, but because there are no data on effectiveness in the literature, this cohort will not be included in primary analyses and instead will be included only in secondary and exploratory analyses. We will examine potential preventive effects of BI (either) on subjects with lower level drug use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Brief Intervention | Experimental | Behavioral: Standard Brief Intervention |
| Enhanced Brief Intervention | Experimental | Behavioral: Enhanced Brief Intervention |
| Control | Active comparator | Behavioral: Control: Information and Feedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or older
- Arrived for a visit in primary care
- ASSIST Substance Specific Involvement Score of greater than or equal to 4 for subjects included in primary analyses; ASSIST Substance-Specific Involvement Scores of 2 or 3 for subjects included only in exploratory analyses
- No previous MASBIRT intervention in the past 3 months
- Fluent in English or Spanish
Key exclusion criteria (9 listed)
- NOT 18 years of age or older
- NOT Arrived for a visit in primary care
- NO ASSIST Substance Specific Involvement Score of greater than or equal to 4 for subjects included in primary analyses; or NO ASSIST Substance-Specific Involvement Scores of 2 or 3 for subjects included only in exploratory analyses
- ANY previous MASBIRT intervention in the past 3 months
- NOT Fluent in English or Spanish
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 Brief InterventionAlso: BI-SIntervention: Structured, brief negotiated interview. Intervention preparation and content: Preparation: review of ASSIST results; Content: The intervention involves 4 major parts: 1) establishing rapport and asking the subject for permission to raise the topic of drug use; 2) exploring the pros and cons of use; 3) providing feedback and assessing readiness to change; and 4) advising and negotiating a plan. Counselor: Health Promotion Advocate, High School graduate or GED minimum Training specific to the brief intervention: Didactic and experiential; competency demonstrated by observation and/or video recordings which are content scored using a standardized form. Contacts, Duration: One, 10-15 minutes. Communication content delivered to primary care physician: Results of screening and BI. Supervision: Weekly 1-hour meeting with supervisor to discuss job performance and discuss cases; biannual shadowing by supervisor. | Behavioural | Standard Brief Intervention |
| Enhanced Brief InterventionAlso: BI-EIntervention: Less structured, motivational interview. Intervention preparation and content: Preparation: review of ASSIST, drug consequences (SIP-D), risk behaviors, CIDI Short Form, and medical record for discussion; Content: Motivational interviewing discussing above. Counselor: Master's level/Doctoral student. Training specific to the brief intervention: Didactic and experiential, followed by additional work towards, and confirmation of, proficiency using audio recordings coded for motivational interviewing content. Contacts, Duration: One plus offer of one optional booster contact, each 30-45 minutes; 2nd by telephone or in person depending on subject's preference; availability of counselor for further readiness discussions. Communication content delivered to primary care physician: Results of screening, BI, and plan including follow-up. Supervision: Weekly 1.5-hour meeting with supervisor with review of coded audio recordings. | Behavioural | Enhanced Brief Intervention |
| Control: Information and FeedbackSubjects randomized to the control group will not receive a BI at enrollment. But, all study subjects will receive screening and its results as part of the informed consent process (that they are at least at risk for drug use health hazards) along with a written list of resources available, including local options. | Behavioural | Control |
Primary outcome
Drug use
Time frame: Six Months
4 secondary outcomes
Drug use consequences
Time frame: Six Months
HIV risk behaviors
Time frame: Six Months
Substance abuse treatment utilization
Time frame: Six Months
Costs
Time frame: Six 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 2 Oct 2014.
- Derived from this study: PubMed 26809204Alford DP, German JS, Samet JH, Cheng DM, Lloyd-Travaglini CA, Saitz R. Primary Care Patients with Drug Use Report Chronic Pain and Self-Medicate with Alcohol and Other Drugs. J Gen Intern Med. 2016 May;31(5):486-91. doi: 10.1007/s11606-016-3586-5. Epub 2016 Jan 25.
- Derived from this study: PubMed 25096690Saitz R, Palfai TP, Cheng DM, Alford DP, Bernstein JA, Lloyd-Travaglini CA, Meli SM, Chaisson CE, Samet JH. Screening and brief intervention for drug use in primary care: the ASPIRE randomized clinical trial. JAMA. 2014 Aug 6;312(5):502-13. doi: 10.1001/jama.2014.7862.
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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.
Richard Saitz, MD principal investigator
Boston Medical Center
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 Standard Brief Intervention and Enhanced Brief Intervention in people with Drug Usage and Drug Abuse, run by Boston Medical Center at 1 site 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 9 inclusion and 9 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 Oct 2014. 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 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 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?
Drug use (time frame: Six Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00876941, which also lists 2 linked publications.
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 Oct 2014.