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Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

Extending Long-term Outcomes Through an Adaptive Aftercare Intervention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02143063
Enrollment
274
Registered
2014-05-20
Start date
2014-08-31
Completion date
2020-10-31
Last updated
2022-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Use Disorder, Contingency Management

Brief 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. 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.

Interventions

BEHAVIORALprize contingency management on a traditional twice weekly schedule for cocaine abstinence
BEHAVIORALprize contingency management on a variable interval schedule for cocaine abstinence
BEHAVIORALstandard care

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
UConn Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* serious, uncontrolled psychiatric illness * in recovery from pathological gambling * do not speak English

Design outcomes

Primary

MeasureTime frameDescription
Longest Duration of Abstinence From Cocainebaseline through 6 monthsLongest duration of consecutive cocaine-negative urine toxicology tests

Secondary

MeasureTime frameDescription
Longest Duration of Abstinence From All Substances Testedbaseline through 6 monthsBased on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines)

Countries

United States

Participant flow

Participants by arm

ArmCount
Standard Care
standard care standard care
61
Standard Care Plus Traditional Contingency Managment
prize contingency management on a traditional twice weekly schedule for cocaine abstinence prize contingency management on a traditional twice weekly schedule for cocaine abstinence standard care
105
Standard Care Plus Variable Interval Contingency Management
prize contingency management on a variable interval schedule for cocaine abstinence prize contingency management on a variable interval schedule for cocaine abstinence standard care
108
Total274

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath011
Overall StudyLost to Follow-up162829
Overall StudyWithdrawal by Subject010

Baseline characteristics

CharacteristicStandard CareTotalStandard Care Plus Variable Interval Contingency ManagementStandard Care Plus Traditional Contingency Managment
Age, Continuous39.9 years
STANDARD_DEVIATION 9.2
40.1 years
STANDARD_DEVIATION 9.7
39.7 years
STANDARD_DEVIATION 10.1
40.7 years
STANDARD_DEVIATION 9.6
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants64 Participants27 Participants23 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
47 Participants209 Participants81 Participants81 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants3 Participants0 Participants2 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
16 Participants81 Participants30 Participants35 Participants
Race (NIH/OMB)
More than one race
5 Participants15 Participants6 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants26 Participants8 Participants12 Participants
Race (NIH/OMB)
White
33 Participants149 Participants64 Participants52 Participants
Region of Enrollment
United States
61 participants274 participants108 participants105 participants
Sex: Female, Male
Female
32 Participants147 Participants58 Participants57 Participants
Sex: Female, Male
Male
29 Participants127 Participants50 Participants48 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 611 / 1051 / 108
other
Total, other adverse events
12 / 617 / 1059 / 108
serious
Total, serious adverse events
46 / 6166 / 10577 / 108

Outcome results

Primary

Longest Duration of Abstinence From Cocaine

Longest duration of consecutive cocaine-negative urine toxicology tests

Time frame: baseline through 6 months

ArmMeasureValue (MEDIAN)
Standard CareLongest Duration of Abstinence From Cocaine4.14 weeks
Standard Care Plus Traditional Contingency ManagmentLongest Duration of Abstinence From Cocaine6.64 weeks
Standard Care Plus Variable Interval Contingency ManagementLongest Duration of Abstinence From Cocaine6.93 weeks
p-value: 0.01Wilcoxon (Mann-Whitney)
p-value: 0.78Wilcoxon (Mann-Whitney)
Secondary

Longest Duration of Abstinence From All Substances Tested

Based on breath and urine toxicology tests (alcohol, methamphetamine, cocaine, opioids, THC, amphetamine, benzodiazepines)

Time frame: baseline through 6 months

ArmMeasureValue (MEDIAN)
Standard CareLongest Duration of Abstinence From All Substances Tested4.75 weeks
Standard Care Plus Traditional Contingency ManagmentLongest Duration of Abstinence From All Substances Tested5.93 weeks
Standard Care Plus Variable Interval Contingency ManagementLongest Duration of Abstinence From All Substances Tested5.71 weeks
Comparison: Primary Aim 1: Compare the standard care and standard care plus traditional CM conditionsp-value: 0.02Wilcoxon (Mann-Whitney)
p-value: 0.61Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026