Cocaine Use DisorderNCT02143063
Extending Long-term Outcomes Through an Adaptive Aftercare Intervention
A study testing prize contingency management on a traditional twice weekly schedule for cocaine abstinence and prize contingency management on a variable interval schedule for cocaine abstinence in people with Cocaine Use Disorder and Contingency Management, run by UConn Health at 4 sites in United States.
Trial summary
Reinforcement interventions have pronounced effects on reducing cocaine use. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cocaine Use Disorder, Contingency Management
- What is being tested?
- prize contingency management on a traditional twice weekly schedule for cocaine abstinence and prize contingency management on a variable interval schedule for cocaine abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2014to Oct 2020
- Phase
- Interventional
- 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
- be age 18 years or older
- have a cocaine use disorder diagnosis
- be willing to sign informed consent and able to pass an informed consent quiz
Who cannot join
- serious, uncontrolled psychiatric illness
- in recovery from pathological gambling
- do not speak English
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Regional Network of Programs, Inc.
Bridgeport, Connecticut, 06610
Alcohol and Drug Recovery Centers, Inc.
Hartford, Connecticut, 06112
The Hospital of Central Connecticut at New Britain General
New Britain, Connecticut, 06050
Behavioral Health Network, Inc.
Springfield, Massachusetts, 01104
About this study
Reinforcement interventions have pronounced effects on reducing cocaine use. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care, standard care plus traditional twice weekly reinforcement, or standard care plus adaptive variable interval reinforcement.
Read the detailed description
Reinforcement interventions have pronounced effects on reducing cocaine use. We developed and evaluated a low-cost reinforcement intervention, systematically moving it through the Stages of development to dissemination and broad clinical implementation. In an ongoing project, reinforcement interventions are yielding benefits when reinforcers are provided at treatment initiation and for longer durations. However, less than half of patients remain engaged for 12 weeks with traditional reinforcement interventions, which require frequent attendance for monitoring and reinforcing abstinence. Interventions that extend into aftercare and that are acceptable to and efficacious in preventing long-term relapse are critically needed.
Reinforcement interventions are efficacious during periods they are in effect, and pilot data show that variable interval (VI) reinforcement schedules, once behavior change occurs, hold potential for maintaining gains when administered infrequently. Assessing methods to extend benefits of these interventions is of paramount scientific and clinical concern. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. In this intervention, reinforcement will be available for 24 weeks, on a progressive VI schedule, that adapts according to patient status. Patients who maintain abstinence earn maximum reinforcers as infrequently as every three weeks on average, while frequency of monitoring and reinforcing abstinence will increase in those who relapse until abstinence is re-instated.
To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care (SC), SC+traditional twice weekly reinforcement, or SC+adaptive VI reinforcement. Evaluations will be completed at baseline and throughout 18 months to assess objective and self-reported indices of drug use, psychosocial problems, and HIV risk behaviors. Primary hypotheses are (1) the adaptive VI reinforcement intervention will improve outcomes relative to standard care during the treatment period and throughout follow-up, and (2) the adaptive VI reinforcement intervention will improve outcomes relative to the traditional reinforcement system. This study will also evaluate the roles of cognitive control and treatment outcome. Patients with better cognitive control are expected to maintain longer durations of abstinence across conditions. If these measures differentially relate to outcomes across treatments, such results suggest the potential of pairing reinforcement interventions to individuals most likely to benefit from them; they may also indicate possible markers of response in a treatment-specific manner. If cognitive indices mediate treatment response, future studies can refine interventions to improve cognitive processes and long-term outcomes.
- Conditions
- Cocaine Use Disorder, Contingency Management
- Being tested
- prize contingency management on a traditional twice weekly schedule for cocaine abstinence, prize contingency management on a variable interval schedule for cocaine abstinence, standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prize contingency management on a traditional twice weekly schedule for cocaine abstinenceBehavioural
prize contingency management on a variable interval schedule for cocaine abstinenceBehavioural
standard careBehavioural
| Study group | Role | What they receive |
|---|---|---|
| standard care | Active comparator | standard care Receives: Behavioral: standard care |
| standard care plus traditional contingency managment | Active comparator | prize contingency management on a traditional twice weekly schedule for cocaine abstinence Receives: Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinence; Behavioral: standard care |
| standard care plus variable interval contingency management | Experimental | prize contingency management on a variable interval schedule for cocaine abstinence Receives: Behavioral: prize contingency management on a variable interval schedule for cocaine abstinence; Behavioral: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longest Duration of Abstinence From Cocaine
Longest duration of consecutive cocaine-negative urine toxicology tests
Measured: baseline through 6 months
Secondary outcomes (1)
Longest Duration of Abstinence From All Substances Tested
Based on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines)
Measured: baseline through 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startAug 2014
- Primary completionOct 2020
- Study completionOct 2020
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.
- Other trials for Cocaine 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
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sheila Alessi, UConn Health
- Investigators
- Nancy Petry, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143063
- Sponsor's protocol ID
- 14-090H-2
- Other IDs
- P50DA009241
- Status last verified
- Jan 2022
- First submitted
- 24 Feb 2014
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending Long-term Outcomes Through an Adaptive Aftercare Intervention
- ClinicalTrials.gov ID
- NCT02143063
- Acronym / sponsor ID
- 14-090H-2
- Conditions
- Cocaine Use Disorder, Contingency Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Aug 2014 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 20 May 2014 (estimated)
- Results
- Posted 30 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Reinforcement interventions have pronounced effects on reducing cocaine use. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care, standard care plus traditional twice weekly reinforcement, or standard care plus adaptive variable interval reinforcement.
Detailed description
Reinforcement interventions have pronounced effects on reducing cocaine use. We developed and evaluated a low-cost reinforcement intervention, systematically moving it through the Stages of development to dissemination and broad clinical implementation. In an ongoing project, reinforcement interventions are yielding benefits when reinforcers are provided at treatment initiation and for longer durations. However, less than half of patients remain engaged for 12 weeks with traditional reinforcement interventions, which require frequent attendance for monitoring and reinforcing abstinence. Interventions that extend into aftercare and that are acceptable to and efficacious in preventing long-term relapse are critically needed.
Reinforcement interventions are efficacious during periods they are in effect, and pilot data show that variable interval (VI) reinforcement schedules, once behavior change occurs, hold potential for maintaining gains when administered infrequently. Assessing methods to extend benefits of these interventions is of paramount scientific and clinical concern. This study will evaluate a novel approach in which reinforcement frequency varies by patient performance. In this intervention, reinforcement will be available for 24 weeks, on a progressive VI schedule, that adapts according to patient status. Patients who maintain abstinence earn maximum reinforcers as infrequently as every three weeks on average, while frequency of monitoring and reinforcing abstinence will increase in those who relapse until abstinence is re-instated.
To test efficacy, 280 patients with cocaine use disorder will be randomly assigned to: standard care (SC), SC+traditional twice weekly reinforcement, or SC+adaptive VI reinforcement. Evaluations will be completed at baseline and throughout 18 months to assess objective and self-reported indices of drug use, psychosocial problems, and HIV risk behaviors. Primary hypotheses are (1) the adaptive VI reinforcement intervention will improve outcomes relative to standard care during the treatment period and throughout follow-up, and (2) the adaptive VI reinforcement intervention will improve outcomes relative to the traditional reinforcement system. This study will also evaluate the roles of cognitive control and treatment outcome. Patients with better cognitive control are expected to maintain longer durations of abstinence across conditions. If these measures differentially relate to outcomes across treatments, such results suggest the potential of pairing reinforcement interventions to individuals most likely to benefit from them; they may also indicate possible markers of response in a treatment-specific manner. If cognitive indices mediate treatment response, future studies can refine interventions to improve cognitive processes and long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| standard care | Active comparator | Behavioral: standard carestandard care |
| standard care plus traditional contingency managment | Active comparator | Behavioral: prize contingency management on a traditional twice weekly schedule for cocaine abstinence, Behavioral: standard careprize contingency management on a traditional twice weekly schedule for cocaine abstinence |
| standard care plus variable interval contingency management | Experimental | Behavioral: prize contingency management on a variable interval schedule for cocaine abstinence, Behavioral: standard careprize contingency management on a variable interval schedule for cocaine abstinence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- be age 18 years or older
- have a cocaine use disorder diagnosis
- be willing to sign informed consent and able to pass an informed consent quiz
Key exclusion criteria (3 listed)
- serious, uncontrolled psychiatric illness
- in recovery from pathological gambling
- do not speak English
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 |
|---|---|---|
| prize contingency management on a traditional twice weekly schedule for cocaine abstinence | Behavioural | standard care plus traditional contingency managment |
| prize contingency management on a variable interval schedule for cocaine abstinence | Behavioural | standard care plus variable interval contingency management |
| standard care | Behavioural | standard care, standard care plus traditional contingency managment, standard care plus variable interval contingency management |
Primary outcome
Longest Duration of Abstinence From Cocaine
Time frame: baseline through 6 months
Longest duration of consecutive cocaine-negative urine toxicology tests
1 secondary outcome
Longest Duration of Abstinence From All Substances Tested
Time frame: baseline through 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy Petry, Ph.D. principal investigator
UConn Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prize contingency management on a traditional twice weekly schedule for cocaine abstinence and prize contingency management on a variable interval schedule for cocaine abstinence in people with Cocaine Use Disorder and Contingency Management, run by UConn Health at 4 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 3 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2021). 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?
Longest Duration of Abstinence From Cocaine (time frame: baseline through 6 months). 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 13 Jan 2022.