Substance Use DisordersNCT00105729
Substance Abuse Self-Help Group Referral: Outcomes and Services Use
A study testing Intensive referral to 12-step self-help groups in people with Substance Use Disorders, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Intensive referral to 12-step self-help groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Apr 2005
- 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
- Consecutive substance use disorder outpatients at VA PA HCS and is not cognitively impaired.
Who cannot join
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Official title: Substance Abuse Self-Help Group Referral: Outcome and Services Use
Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services.
Read the detailed description
Background:
Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services.
Objectives:
The first objective was to implement and validate procedures to help counselors make effective referrals to SHGs for SUD patients. This project randomly assigned SUD outpatients to a standard referral or an intensive referral condition. We are determining the extent to which intensive referral increased patients' SHG attendance and involvement in comparison to standard referral. The second objective is to determine whether patients who received intensive referral to SHGs have better substance use and functioning outcomes over the 1-year follow-up period, and less use of formal treatment services, thereby reducing costs for VA, than those who received standard referral. The long-term goal is to develop and implement guidelines to facilitate SUD patients' participation in SHGs and thereby improve their quality of life and decrease their use of VA's specialized SUD treatment services.
Methods:
This project used a randomized design in which 345 patients entering VA outpatient SUD treatment were randomly assigned to either standard or intensive referral to SHGs. Standard referral consisted of the counselor recommending SHG participation. The keys to intensive referral included the counselor facilitating direct contact between the patient and a member of the SHG, and counselor follow-up on the recommendation for self-help. Patients were followed at 6 months and 1 year to determine whether intensive referral resulted in more self-help attendance and involvement; in better substance use and functioning outcomes (using the Addiction Severity Index); and in less use of VA services and lower treatment costs (using methods of the VA Health Economics Resource Center). To make these determinations, we are conducting analyses at each follow-up, and then will use hierarchical linear modeling to examine the benefits of intensive referral over time.
Status:
Project work is ongoing.
- Conditions
- Substance Use Disorders
- Being tested
- Intensive referral to 12-step self-help groups
- Keywords
- Self-help groups, Referral and consultation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive referral to 12-step self-help groupsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Intensive referral to 12-step self-help groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
DRUG USE AND ALCOHOL USE AT 6 MONTHS AND 1 YEAR
Secondary outcomes (1)
SUBSTANCE ABUSE AND PSYCHIATRIC SERVICES USE AT 6 MONTHS AND 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2005 (estimated)
- Study startJan 2003
- Study completionApr 2005
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 Substance Use DisordersStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 345 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Christine Timko, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105729
- Sponsor's protocol ID
- IIR 20-067
- Status last verified
- Sep 2006
- First submitted
- 16 Mar 2005
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Timko C, Billow R, DeBenedetti A. Determinants of 12-step group affiliation and moderators of the affiliation-abstinence relationship. Drug Alcohol Depend. 2006 Jun 28;83(2):111-21. doi: 10.1016/j.drugalcdep.2005.11.005. Epub 2005 Dec 9.
PubMed 16338102Timko C, DeBenedetti A. A randomized controlled trial of intensive referral to 12-step self-help groups: one-year outcomes. Drug Alcohol Depend. 2007 Oct 8;90(2-3):270-9. doi: 10.1016/j.drugalcdep.2007.04.007. Epub 2007 May 24.
PubMed 17524574
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Abuse Self-Help Group Referral: Outcome and Services Use
- ClinicalTrials.gov ID
- NCT00105729
- Acronym / sponsor ID
- IIR 20-067
- Conditions
- Substance Use Disorders
- Keywords
- Self-help groups, Referral and consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2003
- Study completion
- Apr 2005 (actual)
- First posted
- 17 Mar 2005 (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.
Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services.
Detailed description
Background:
Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services.
Objectives:
The first objective was to implement and validate procedures to help counselors make effective referrals to SHGs for SUD patients. This project randomly assigned SUD outpatients to a standard referral or an intensive referral condition. We are determining the extent to which intensive referral increased patients' SHG attendance and involvement in comparison to standard referral. The second objective is to determine whether patients who received intensive referral to SHGs have better substance use and functioning outcomes over the 1-year follow-up period, and less use of formal treatment services, thereby reducing costs for VA, than those who received standard referral. The long-term goal is to develop and implement guidelines to facilitate SUD patients' participation in SHGs and thereby improve their quality of life and decrease their use of VA's specialized SUD treatment services.
Methods:
This project used a randomized design in which 345 patients entering VA outpatient SUD treatment were randomly assigned to either standard or intensive referral to SHGs. Standard referral consisted of the counselor recommending SHG participation. The keys to intensive referral included the counselor facilitating direct contact between the patient and a member of the SHG, and counselor follow-up on the recommendation for self-help. Patients were followed at 6 months and 1 year to determine whether intensive referral resulted in more self-help attendance and involvement; in better substance use and functioning outcomes (using the Addiction Severity Index); and in less use of VA services and lower treatment costs (using methods of the VA Health Economics Resource Center). To make these determinations, we are conducting analyses at each follow-up, and then will use hierarchical linear modeling to examine the benefits of intensive referral over time.
Status:
Project work is ongoing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Intensive referral to 12-step self-help groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive substance use disorder outpatients at VA PA HCS and is not cognitively impaired.
Key exclusion criteria (1 listed)
- Cognitive impairment
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 |
|---|---|---|
| Intensive referral to 12-step self-help groups | Behavioural | Arm 1 |
Primary outcome
DRUG USE AND ALCOHOL USE AT 6 MONTHS AND 1 YEAR
1 secondary outcome
SUBSTANCE ABUSE AND PSYCHIATRIC SERVICES USE AT 6 MONTHS AND 1 YEAR
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 7 Apr 2015.
- Results publication: PubMed 16338102Timko C, Billow R, DeBenedetti A. Determinants of 12-step group affiliation and moderators of the affiliation-abstinence relationship. Drug Alcohol Depend. 2006 Jun 28;83(2):111-21. doi: 10.1016/j.drugalcdep.2005.11.005. Epub 2005 Dec 9.
- Results publication: PubMed 17524574Timko C, DeBenedetti A. A randomized controlled trial of intensive referral to 12-step self-help groups: one-year outcomes. Drug Alcohol Depend. 2007 Oct 8;90(2-3):270-9. doi: 10.1016/j.drugalcdep.2007.04.007. Epub 2007 May 24.
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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.
Christine Timko, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive referral to 12-step self-help groups in people with Substance Use Disorders, run by US Department of Veterans Affairs 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 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 7 Apr 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 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?
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 AND ALCOHOL USE AT 6 MONTHS AND 1 YEAR. 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 NCT00105729, 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 7 Apr 2015.