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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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.

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 groups in NCT02143063
Study groupRoleWhat they receive
standard careActive comparatorstandard care
Receives: Behavioral: standard care
standard care plus traditional contingency managmentActive comparatorprize 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 managementExperimentalprize 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.

  1. Longest Duration of Abstinence From Cocaine

    Longest duration of consecutive cocaine-negative urine toxicology tests

    Measured: baseline through 6 months

Secondary outcomes (1)
  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.

  1. First posted20 May 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionOct 2020
  4. Study completionOct 2020

Resources

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)
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
Data monitoring committee
Yes

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.

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