Substance Use DisordersPhase 2NCT00288886
Reinforcement of Abstinence and Continuing Care in Substance Abuse Treatment
A Phase 2 study testing Contracting, Prompting and Reinforcement arm in people with Substance Use Disorders and Alcohol Abuse, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders, Alcohol Abuse, Alcoholism
- What is being tested?
- Contracting, Prompting and Reinforcement arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants were recruited from consecutive veterans who successful complete the 28-day SARRTP at the Salem VAMC and the 21-day SARRTP at the Jackson VAMC. Participants who are uninterested in aftercare, who have unstable housing or other factors that made aftercare participation difficult, will be included to maximize the generalizability of our results.
Who cannot join
- Individuals who did not live within a 60-minute drive, and those who did not have transportation and a work schedule allowing attendance of aftercare were ineligible.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
G.V. (Sonny) Montgomery VA Medical Center, Jackson, MS
Jackson, Mississippi, 39216
Salem VA Medical Center, Salem, VA
Salem, Virginia, 24153
About this study
Official title: Reinforcement of Abstinence and Attendance in Substance Abuse Treatment
The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Final results of our recently completed HSR\&D clinical trial suggest CPR meaningfully impacts aftercare adherence and abstinence rates. However, CPR did not impact abstinence rates at earlier follow-up points, other important measures of treatment outcome, or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites has not been established. Thus, the intervention has been modified and pilot testing of this improved version of CPR, which includes contingent reinforcement of abstinence and improved prompting of AA/NA attendance (CPR+), shows promising results. We are conducting a multi-site randomized clinical trial to examine the effectiveness of CPR+. We recruited 183 veterans seeking residential treatment at the Salem and Jackson VAMCs. Our primary hypothesis is that the CPR group will have higher 1-year abstinence rates compared to the STX group. Our secondary hypotheses are that the CPR will be particularly effective for individuals with co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations, and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after participants enter treatment and compared to baseline levels. The current study will seek to extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing care adherence and greater impact on treatment outcome. Dissemination and implementation efforts will be ongoing for this brief, inexpensive intervention, which offers an important means to improve participation and outcome for individuals seeking SUD treatment within the VAMC. Data collection and analysis has been completed.
Read the detailed description
The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Final results of our recently completed HSR\&D clinical trial suggest CPR meaningfully impacts aftercare adherence and abstinence rates. Among CPR participants, 55% met the VA's SUD continuity of care performance measure (attending at least 2 therapy sessions each month for 3 months), compared to 36% of those in standard treatment (STX). On the primary outcome variable, 57% of the participants in the CPR condition were abstinent at the 1-year follow-up compared to 37% of those in STX. Post hoc moderator analyses also indicate that the intervention was particularly effective for participants with co-morbid psychiatric disorders. However, CPR did not impact abstinence rates at earlier follow-up points, other important measures of treatment outcome, or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites has not been established. Thus, the intervention has been modified and pilot testing of this improved version of CPR, which includes contingent reinforcement of abstinence and improved prompting of AA/NA attendance (CPR+), shows promising results. We conducted a multi-site randomized clinical trial to examine the effectiveness of CPR+ with 2 specific goals: 1) to compare CPR+ to STX on adherence to continuing care (i.e., AA/NA participation and aftercare therapy) and 2) to assess its effect on treatment outcome. We recruited 183 veterans seeking residential treatment at the Salem and Jackson VAMCs. Our primary hypothesis is that the CPR group will have higher 1-year abstinence rates compared to the STX group. Our secondary hypotheses are that the CPR will be particularly effective for individuals with co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations, and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after participants enter treatment and compared to baseline levels using the Form-90 Interview, the Addiction Severity Index (ASI), questionnaire responses, and substance use screens. Treatment adherence will be measured using VA databases, medical records, therapist ratings, and questionnaire responses. Abstinence rates will be analyzed using a logistic regression model in which the parameters of interest are estimated using Generalized Estimating Equations. Secondary outcomes will be analyzed using both marginal and linear mixed-effects models as appropriate. The current study sought to extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing care adherence and greater impact on treatment outcome. Dissemination and implementation efforts are ongoing for this brief, inexpensive intervention, which offers an important means to improve participation and outcome for individuals seeking SUD treatment within the VAMC.
- Being tested
- Contracting, Prompting and Reinforcement arm, Control arm
- Keywords
- Compliance, Aftercare, Reinforcement, social, Alcoholics Anonymous, Support Groups, Treatment Outcome
- Medical subject headings
- Substance-Related Disorders, Alcoholism, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contracting, Prompting and Reinforcement armBehavioural
Contracting, prompting and reinforcement of continuing care and abstinence.
Control armBehavioural
Routine residential treatment and orientation to continuing care.
| Study group | Role | What they receive |
|---|---|---|
| Contracts, Prompts and Reinforcement arm | Experimental | Participants were provided with contracting, prompting and reinforcement of continuing care attendance and substance use abstinence. Receives: Behavioral: Contracting, Prompting and Reinforcement arm |
| Control Arm | Active comparator | Participants were provided with routine care- they did not receive contracting, prompting and reinforcement of continuing care attendance and substance use abstinence. Receives: Behavioral: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90
Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.
Measured: Assessed at 12 months
Secondary outcomes (6)
Abstinence Rate (During the Preceding 90 Days) at 3- and 6-months Follow-up Point as Assessed by the Form-90
Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.
Measured: Assessed at 3 and 6 months
Days Until First Use of Alcohol or Drugs
Measured: Baseline to 12 months
Aftercare Attendance
Measures of aftercare attendance include: Percentage of participants who attended at least 1 aftercare session; percentage of participants who attended at least 2 aftercare sessions/month for at least 3, 6, 9 and 12 months; and percentage of participants who passed the VAMC's SUD continuity of care performance measure (a benchmark for retention of clients in aftercare for at least two visits each month for 3 months following initial treatment)
Measured: Assessed at 3-, 6-, 9-, and 12-months
Self-help Support Group Attendance
Measured: Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year
Days of Substance Abuse (Across the Prior 90 Days)
Measured: Assessed at Baseline, 3-, 6-, and 12-month follow-up
Rates of Hospitalization (Across the Prior 90 Days)
Number of days hospitalized for any reason per the previous 90 days
Measured: Assessed at Baseline, 3-, 6-, and 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 Feb 2006 (estimated)
- Study startMar 2007
- Primary completionJun 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steven J Lash, PhD, Principal investigator, Salem VA Medical Center, Salem, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288886
- Sponsor's protocol ID
- IIR 03-267
- Status last verified
- Jul 2014
- First submitted
- 6 Feb 2006
- Last updated
- 24 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lash SJ, Timko C, Curran GM, McKay JR, Burden JL. Implementation of evidence-based substance use disorder continuing care interventions. Psychol Addict Behav. 2011 Jun;25(2):238-51. doi: 10.1037/a0022608.
PubMed 21443297Lash SJ, Burden JL, Parker JD, Stephens RS, Budney AJ, Horner RD, Datta S, Jeffreys AS, Grambow SC. Contracting, prompting and reinforcing substance use disorder continuing care. J Subst Abuse Treat. 2013 Apr;44(4):449-56. doi: 10.1016/j.jsat.2012.09.008. Epub 2012 Oct 31.
PubMed 23122489
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reinforcement of Abstinence and Attendance in Substance Abuse Treatment
- ClinicalTrials.gov ID
- NCT00288886
- Acronym / sponsor ID
- IIR 03-267
- Keywords
- Compliance, Aftercare, Reinforcement, social, Alcoholics Anonymous, Support Groups, Treatment Outcome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2007
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Feb 2006 (estimated)
- Results
- Posted 29 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Final results of our recently completed HSR\&D clinical trial suggest CPR meaningfully impacts aftercare adherence and abstinence rates. However, CPR did not impact abstinence rates at earlier follow-up points, other important measures of treatment outcome, or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites has not been established. Thus, the intervention has been modified and pilot testing of this improved version of CPR, which includes contingent reinforcement of abstinence and improved prompting of AA/NA attendance (CPR+), shows promising results. We are conducting a multi-site randomized clinical trial to examine the effectiveness of CPR+. We recruited 183 veterans seeking residential treatment at the Salem and Jackson VAMCs. Our primary hypothesis is that the CPR group will have higher 1-year abstinence rates compared to the STX group. Our secondary hypotheses are that the CPR will be particularly effective for individuals with co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations, and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after participants enter treatment and compared to baseline levels. The current study will seek to extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing care adherence and greater impact on treatment outcome. Dissemination and implementation efforts will be ongoing for this brief, inexpensive intervention, which offers an important means to improve participation and outcome for individuals seeking SUD treatment within the VAMC. Data collection and analysis has been completed.
Detailed description
The Contracts, Prompts, and Social Reinforcement (CPR) intervention was designed to address the continuing care adherence needs of veterans presenting for substance use disorder (SUD) treatment. Final results of our recently completed HSR\&D clinical trial suggest CPR meaningfully impacts aftercare adherence and abstinence rates. Among CPR participants, 55% met the VA's SUD continuity of care performance measure (attending at least 2 therapy sessions each month for 3 months), compared to 36% of those in standard treatment (STX). On the primary outcome variable, 57% of the participants in the CPR condition were abstinent at the 1-year follow-up compared to 37% of those in STX. Post hoc moderator analyses also indicate that the intervention was particularly effective for participants with co-morbid psychiatric disorders. However, CPR did not impact abstinence rates at earlier follow-up points, other important measures of treatment outcome, or AA/NA support group attendance. Furthermore, the generalizability of CPR to other sites has not been established. Thus, the intervention has been modified and pilot testing of this improved version of CPR, which includes contingent reinforcement of abstinence and improved prompting of AA/NA attendance (CPR+), shows promising results. We conducted a multi-site randomized clinical trial to examine the effectiveness of CPR+ with 2 specific goals: 1) to compare CPR+ to STX on adherence to continuing care (i.e., AA/NA participation and aftercare therapy) and 2) to assess its effect on treatment outcome. We recruited 183 veterans seeking residential treatment at the Salem and Jackson VAMCs. Our primary hypothesis is that the CPR group will have higher 1-year abstinence rates compared to the STX group. Our secondary hypotheses are that the CPR will be particularly effective for individuals with co-morbid psychiatric disorders, and that the CPR+ group will remain in AA/NA and in aftercare for a longer duration, have fewer days of substance use, fewer hospitalizations, and lower costs of care. Treatment outcome will be measured 3-, 6-, and 12-months after participants enter treatment and compared to baseline levels using the Form-90 Interview, the Addiction Severity Index (ASI), questionnaire responses, and substance use screens. Treatment adherence will be measured using VA databases, medical records, therapist ratings, and questionnaire responses. Abstinence rates will be analyzed using a logistic regression model in which the parameters of interest are estimated using Generalized Estimating Equations. Secondary outcomes will be analyzed using both marginal and linear mixed-effects models as appropriate. The current study sought to extend past findings to show longer-term effectiveness of the CPR+ intervention on continuing care adherence and greater impact on treatment outcome. Dissemination and implementation efforts are ongoing for this brief, inexpensive intervention, which offers an important means to improve participation and outcome for individuals seeking SUD treatment within the VAMC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contracts, Prompts and Reinforcement arm | Experimental | Behavioral: Contracting, Prompting and Reinforcement armParticipants were provided with contracting, prompting and reinforcement of continuing care attendance and substance use abstinence. |
| Control Arm | Active comparator | Behavioral: Control armParticipants were provided with routine care- they did not receive contracting, prompting and reinforcement of continuing care attendance and substance use abstinence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants were recruited from consecutive veterans who successful complete the 28-day SARRTP at the Salem VAMC and the 21-day SARRTP at the Jackson VAMC. Participants who are uninterested in aftercare, who have unstable housing or other factors that made aftercare participation difficult, will be included to maximize the generalizability of our results.
Key exclusion criteria (1 listed)
- Individuals who did not live within a 60-minute drive, and those who did not have transportation and a work schedule allowing attendance of aftercare were ineligible.
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 Reinforcement armContracting, prompting and reinforcement of continuing care and abstinence. | Behavioural | Contracts, Prompts and Reinforcement arm |
| Control armRoutine residential treatment and orientation to continuing care. | Behavioural | Control Arm |
Primary outcome
Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90
Time frame: Assessed at 12 months
Participants who were abstinent was assessed via Form-90 Interview (Form 90I) is a structured interview that assesses substance use and related behaviors over the previous 90 days employing a calendar-based follow-back method that provides continuous measures of substance use, and has good reliability. Measures include days abstinent, days using alcohol, days using drugs, total number of standard drinks, and days of self help meeting attendance. Briefer versions were constructed to collect data via telephone in instances when participants did not return for in-person interviews. As a reliability check on participants' self-report, a collateral interview was employed when contacting informants. Participants who denied use on the Form-90, but had a positive substance use screen were considered to be not abstinent for that follow-up point.
6 secondary outcomes
Abstinence Rate (During the Preceding 90 Days) at 3- and 6-months Follow-up Point as Assessed by the Form-90
Time frame: Assessed at 3 and 6 months
Days Until First Use of Alcohol or Drugs
Time frame: Baseline to 12 months
Aftercare Attendance
Time frame: Assessed at 3-, 6-, 9-, and 12-months
Self-help Support Group Attendance
Time frame: Assessed over the past 90 days at 3, 6 and 12 months, and cumulative over 1 year
Days of Substance Abuse (Across the Prior 90 Days)
Time frame: Assessed at Baseline, 3-, 6-, and 12-month follow-up
Rates of Hospitalization (Across the Prior 90 Days)
Time frame: Assessed at Baseline, 3-, 6-, and 12-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21443297Lash SJ, Timko C, Curran GM, McKay JR, Burden JL. Implementation of evidence-based substance use disorder continuing care interventions. Psychol Addict Behav. 2011 Jun;25(2):238-51. doi: 10.1037/a0022608.
- Results publication: PubMed 23122489Lash SJ, Burden JL, Parker JD, Stephens RS, Budney AJ, Horner RD, Datta S, Jeffreys AS, Grambow SC. Contracting, prompting and reinforcing substance use disorder continuing care. J Subst Abuse Treat. 2013 Apr;44(4):449-56. doi: 10.1016/j.jsat.2012.09.008. Epub 2012 Oct 31.
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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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Contracting, Prompting and Reinforcement arm in people with Substance Use Disorders and Alcohol Abuse, run by US Department of Veterans Affairs at 2 sites 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 24 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 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Abstinence Rate (During the Preceding 90 Days) at 12 Months Follow-up Point as Assessed by the Form-90 (time frame: Assessed at 12 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 NCT00288886, 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 24 Apr 2015.