Substance DependenceNCT00057187
Improving Substance Abuse Treatment Aftercare Adherence and Outcome
A study testing Contracting, Prompting and Reinforcing in people with Substance Dependence and Compliance, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Dependence, Compliance, Treatment Outcome
- What is being tested?
- Contracting, Prompting and Reinforcing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Jan 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All graduates of the Salem VA's SARRTP who: live within a 60 minute drive of the Salem VAMC, or 1 of our 5 SARRTP outreach clinics; have transportation and a job schedule that allows them to attend outpatient aftercare therapy.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153
About this study
Although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome.
Read the detailed description
Background:
Although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome.
Objectives:
The objectives of the study were: 1) to compare the effectiveness of an aftercare intervention consisting of a participation contract, attendance prompts, and attendance reinforcers (CPR) to a standard treatment (STX) on adherence to therapy; and 2) to assess the effects of this intervention on treatment outcome
Methods:
We recruited 150 veterans from the Salem VAMC�s SARRTP who could participate in aftercare. Our population is similar to those in other VA�s (97% male, 54% Caucasian, 46% minority, 49 years mean age, 44% alcohol dependent only, 56% drug dependent, and 44% with a dual diagnosis). In this randomized clinical trial, treatment adherence and outcome were measured at baseline and 3-, 6- and 12-months after participants entered treatment using interviews, questionnaires, alcohol and drug screens, VA medical records, and therapist ratings. The study design is a repeated measures nested cohort design, with an intervention and a standard care group. The primary outcome, abstinence rate, will be analyzed using a logistic regression model in which the parameters of interest are estimated using Generalized Estimating Equations (GEE).
Status:
Participant recruitment and follow-up interviews were completed in June 2003 and August 2004, respectively. The HSR\&D final report was submitted in April 2005. The main results paper and additional papers will be submitted for publication in 2005.
- Conditions
- Substance Dependence, Compliance, Treatment Outcome
- Being tested
- Contracting, Prompting and Reinforcing
- Medical subject headings
- Substance-Related Disorders, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contracting, Prompting and ReinforcingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Not described Receives: Behavioral: Contracting, Prompting and Reinforcing |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2003 (estimated)
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Substance DependenceStudies 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
- None (open label)
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Virginia Polytechnic Institute and State University, Duke University
- Responsible party
- Sponsor
- Investigators
- Steven J Lash, PhD, Principal investigator, Salem VA Medical Center, Salem, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00057187
- Sponsor's protocol ID
- IIR 99-282
- Status last verified
- Feb 2007
- First submitted
- 27 Mar 2003
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lash SJ, Burden JL, Monteleone BR, Lehmann LP. Social reinforcement of substance abuse treatment aftercare participation: Impact on outcome. Addict Behav. 2004 Feb;29(2):337-42. doi: 10.1016/j.addbeh.2003.08.008.
PubMed 14732421DeMarce JM, Lash SJ, Stephens RS, Grambow SC, Burden JL. Promoting continuing care adherence among substance abusers with co-occurring psychiatric disorders following residential treatment. Addict Behav. 2008 Sep;33(9):1104-12. doi: 10.1016/j.addbeh.2008.02.008. Epub 2008 Feb 23.
PubMed 18573617DeMarce JM, Burden JL, Lash SJ, Stephens RS, Grambow SC. Convergent validity of the Timeline Followback for persons with comorbid psychiatric disorders engaged in residential substance use treatment. Addict Behav. 2007 Aug;32(8):1582-92. doi: 10.1016/j.addbeh.2006.11.015. Epub 2007 Jan 24.
PubMed 17254716Lash J, Burden L, Fearer A. Contracting, Prompting and Reinforcing Substance Abuse Treatment Aftercare Adherence. Journal of Drug Addiction, Education and Eradication. 2007 Jul 1; 2(3/4):455-490.
Lash SJ, Stephens RS, Burden JL, Grambow SC, DeMarce JM, Jones ME, Lozano BE, Jeffreys AS, Fearer SA, Horner RD. Contracting, prompting, and reinforcing substance use disorder continuing care: a randomized clinical trial. Psychol Addict Behav. 2007 Sep;21(3):387-97. doi: 10.1037/0893-164X.21.3.387.
PubMed 17874889
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
- Improving Substance Abuse Treatment Aftercare Adherence and Outcome
- ClinicalTrials.gov ID
- NCT00057187
- Acronym / sponsor ID
- IIR 99-282
- Conditions
- Substance Dependence, Compliance, Treatment Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Virginia Polytechnic Institute and State University, Duke University
- Study completion
- Jan 2005 (actual)
- First posted
- 31 Mar 2003 (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.
Although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome.
Detailed description
Background:
Although substance abuse treatment continuing care participation is strongly related to positive treatment outcomes, participation rates are low and few interventions have been developed that improve continuing care adherence and outcome.
Objectives:
The objectives of the study were: 1) to compare the effectiveness of an aftercare intervention consisting of a participation contract, attendance prompts, and attendance reinforcers (CPR) to a standard treatment (STX) on adherence to therapy; and 2) to assess the effects of this intervention on treatment outcome
Methods:
We recruited 150 veterans from the Salem VAMC�s SARRTP who could participate in aftercare. Our population is similar to those in other VA�s (97% male, 54% Caucasian, 46% minority, 49 years mean age, 44% alcohol dependent only, 56% drug dependent, and 44% with a dual diagnosis). In this randomized clinical trial, treatment adherence and outcome were measured at baseline and 3-, 6- and 12-months after participants entered treatment using interviews, questionnaires, alcohol and drug screens, VA medical records, and therapist ratings. The study design is a repeated measures nested cohort design, with an intervention and a standard care group. The primary outcome, abstinence rate, will be analyzed using a logistic regression model in which the parameters of interest are estimated using Generalized Estimating Equations (GEE).
Status:
Participant recruitment and follow-up interviews were completed in June 2003 and August 2004, respectively. The HSR\&D final report was submitted in April 2005. The main results paper and additional papers will be submitted for publication in 2005.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Behavioral: Contracting, Prompting and Reinforcing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All graduates of the Salem VA's SARRTP who: live within a 60 minute drive of the Salem VAMC, or 1 of our 5 SARRTP outreach clinics; have transportation and a job schedule that allows them to attend outpatient aftercare therapy.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Contracting, Prompting and Reinforcing | Behavioural | Arm 1 |
Primary outcome
Not reported in the source record.
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 14732421Lash SJ, Burden JL, Monteleone BR, Lehmann LP. Social reinforcement of substance abuse treatment aftercare participation: Impact on outcome. Addict Behav. 2004 Feb;29(2):337-42. doi: 10.1016/j.addbeh.2003.08.008.
- Results publication: PubMed 18573617DeMarce JM, Lash SJ, Stephens RS, Grambow SC, Burden JL. Promoting continuing care adherence among substance abusers with co-occurring psychiatric disorders following residential treatment. Addict Behav. 2008 Sep;33(9):1104-12. doi: 10.1016/j.addbeh.2008.02.008. Epub 2008 Feb 23.
- Results publication: PubMed 17254716DeMarce JM, Burden JL, Lash SJ, Stephens RS, Grambow SC. Convergent validity of the Timeline Followback for persons with comorbid psychiatric disorders engaged in residential substance use treatment. Addict Behav. 2007 Aug;32(8):1582-92. doi: 10.1016/j.addbeh.2006.11.015. Epub 2007 Jan 24.
- Results publicationLash J, Burden L, Fearer A. Contracting, Prompting and Reinforcing Substance Abuse Treatment Aftercare Adherence. Journal of Drug Addiction, Education and Eradication. 2007 Jul 1; 2(3/4):455-490.
- Results publication: PubMed 17874889Lash SJ, Stephens RS, Burden JL, Grambow SC, DeMarce JM, Jones ME, Lozano BE, Jeffreys AS, Fearer SA, Horner RD. Contracting, prompting, and reinforcing substance use disorder continuing care: a randomized clinical trial. Psychol Addict Behav. 2007 Sep;21(3):387-97. doi: 10.1037/0893-164X.21.3.387.
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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.
Steven J Lash, PhD principal investigator
Salem VA Medical Center, Salem, VA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contracting, Prompting and Reinforcing in people with Substance Dependence and Compliance, 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 0 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00057187, which also lists 5 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.