Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01366716 |
Other study ID # |
R01DA021621 |
Secondary ID |
R01DA021621 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 2008 |
Est. completion date |
June 2013 |
Study information
Verified date |
March 2023 |
Source |
Public Health Management Corporation |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Contingency management (CM) is a demonstrably efficacious intervention for substance abuse
and dependence. Although CM protocols have employed a variety of reinforcers, they have
almost exclusively relied upon non-cash privileges (e.g., take-home methadone doses), prizes,
or vouchers that can be exchanged for goods or services. Despite the strong empirical support
for CM, our research suggests that concerns relating to its cost and safety (e.g., potential
for harm caused by rewards undermining intrinsic motivation or being sold to purchase drugs)
have hindered its transfer to real-world practice. The exclusive use of non-cash CM likely
stems from the untested assumption that clients will use cash incentives to buy drugs or
engage in other high-risk behaviors. This assumption is problematic for two reasons. First,
the use of non-cash incentives may add substantial costs and complexity to CM protocols.
Second, the use of non-cash incentives may reduce the efficacy of CM interventions, as
research suggests that cash may be a more effective reinforcer than vouchers. This study
examines both practical and ethical issues relating to cash-based CM procedures. This study
consists of three phases; a main experiment, a "Cash Bowl" pilot, and a "Thinning" Pilot.
Description:
In the main phase of the study, we used a 3-group randomized study to compare the efficacy,
cost-effectiveness, and ethics of a (1) voucher-based CM intervention, (2) cash-based CM
intervention, and (3) non-CM intervention. Two hundred thirty seven consenting
cocaine-dependent clients were randomly assigned to one of the three conditions. In this main
we examined outcomes related to (1) efficacy, including UDS-confirmed abstinence and
counseling attendance; (2) cost-effectiveness; and (3) ethics, including the effects on
intrinsic motivation, drug use, and other high-risk behavior. This investigation addressed
practical issues pertaining to the transfer of CM interventions into community-based
treatment programs, and provided empirical evidence refuting ethical criticisms that have
been levied against the use of cash and CM interventions.
The second phase expanded on the main study with a pilot examination of a probabilistic
reinforcement CM schedule. Probabilistic methods are considered less expensive to implement
yet equally efficacious, as a reward is not provided each time target behaviors are
exhibited, yet similar outcomes result. In this pilot study, an additional 70 participants
were randomized into either a traditional voucher-based probability reinforcement CM
schedule, ("FishBowl" CM), a cash-based probability reinforcement CM schedule ("CashBowl"
CM), or a standard non-CM intervention. As in the main study, we examined these conditions in
terms of efficacy, associated costs and cost-effectiveness, and potential ethical risks.
The third phase of this study is a pilot that seeks to examine the efficacy of a traditional
"thinning" reinforcement schedule compared to an escalating reinforcement schedule or a
treatment-as-usual (non-contingency management control) condition in improving the
during-treatment and post-treatment outcomes of cocaine dependent outpatients in
community-based treatment. Participants will be randomly assigned to one of three treatment
conditions: Escalating CM Condition (n = 15), Traditional ("thinning") CM Condition (n = 15),
and Non-CM Control Condition (n = 15). The intervention will last a total of 16 weeks.
Participants assigned to each of the experimental conditions will receive different
contingency and reward procedures during study weeks 1-12; they will receive identical
contingency and reward procedures during study weeks 13-16. Participants assigned to the
control condition will not receive any contingencies or rewards during the entire 16 week
study. As in the main study, we will examine these conditions in terms of efficacy,
associated costs and cost-effectiveness, and potential ethical risks.