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Cocaine DependenceNCT01283191

Behavioral Incentives to Increase Exercise in Cocaine Dependent Women

A study testing Behavioral Incentives in people with Cocaine Dependence, run by Virginia Commonwealth University at 1 site 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

While physical activity has been associated with decreased craving and increased abstinence rates in smokers, few published studies have examined the effects of exercise on recovery from other drugs such as cocaine. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cocaine Dependence
What is being tested?
Behavioral Incentives
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteUnited States
Study dates
May 2012to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1) at least 18 years of age
  • 2) female
  • 3) meet DSM-IV criteria for Cocaine Dependence (current)
  • 4) medically cleared by the Rubicon staff physician to participate in a regular exercise program
  • 5) able to provide informed consent for study participation.

Who cannot join

  • 1)are pregnant
  • 2)present with cognitive impairment, psychiatric instability, or language barriers that limit their ability to provide informed consent and participate in research assessments.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rubicon, Inc.

    Richmond, Virginia, 23230

Other trials in United States

About this study

Official title: Using Behavioral Incentives to Promote Exercise Compliance in Cocaine Dependent Women

While physical activity has been associated with decreased craving and increased abstinence rates in smokers, few published studies have examined the effects of exercise on recovery from other drugs such as cocaine. One factor that has impeded such research has been low levels of patient compliance with exercise protocols. One robust strategy for promoting and maintaining behavior change is contingency management or Behavioral Incentives (BI). BI delivers incentives (prizes, vouchers) contingent upon target behaviors such as cocaine abstinence (Higgins et al., 1994); treatment attendance (Svikis et al., 1997) and other pro-social behaviors (Kirby et al., 1998). While the literature is replete with studies demonstrating the benefit of BI compared to control conditions (Stitzer \& Petry, 2006), the translation of BI methods from research to clinical practice has met with some resistance. Contributing factors include philosophical differences (e.g., counselors feel extrinsic reinforcement undermines recovery) and practical barriers (e.g., monetary costs of incentives may be prohibitive). The latter concern was addressed by Petry (2005) who developed the "fish bowl" method, which uses escalating variable ratio procedures to reduce per patient costs of BI with similar effect sizes.

As a Stage 1 behavioral therapies development grant (Rounsaville et al., 2001), the primary aim of this research is to pilot test a BI intervention designed to promote regular physical activity in a sample of women receiving inpatient treatment for SUDs. The target behavior, physical activity, will be objectively defined as 30 minutes of observed treadmill walking at any intensity 3 days/week at Level 1, and 30 minutes of higher intensity physical activity that meets ACSM criteria for moderate exercise Level 2. Specifically, a pilot randomized clinical trial will compare rates of physical activity over a 6 week study period in a sample of N=50 women with Cocaine Dependence. All participants will complete baseline assessment, attend a 45-min Health and Fitness (HF) education group, followed by random assignment to either the experimental (BI) or control (C) groups, with equal daily access to on-site treadmills. Those randomized to BI, however, will also be eligible 3 days/week, to receive incentives for completing 30 minutes of treadmill walking.

Read more

Incentives will be dispensed using Petry Fish Bowl methods. Women assigned to the BI group will receive behavioral incentives (in the form of gift cards or prizes) for completing their scheduled exercise sessions (Level 1), and have the opportunity to earn "bonus" draws for meeting moderate intensity exercise criteria, as specified by ACSM (2007, revised) guidelines (Level 2). In Level 1, the number of tokens participants can draw from the gym bag (present study equivalent to "fishbowl") at each visit will be linked to exercise session attendance, with consistent attendance resulting in greater number of draws. In Level 2, the number of tokens a participant can draw from the gym bag will be linked to the intensity of the participant's exercise. Specifically, beginning in Week 2 of the study, participants will be re-evaluated for exercise capability. Those who pass the safety screen will be encouraged to exercise at a higher intensity, and those who do not will be re-evaluated until they obtain safety clearance. Once cleared, if the participant meets criteria for moderate exercise during her scheduled session, then she will be allotted a "bonus" draw (Level 2) for meeting Level 2 criteria, in addition to the escalating number of draws she would received for scheduled exercise session completion (Level 1).

Scheduled treadmill walking will be monitored and recorded for both BI and C group women. Follow-ups will occur at study midpoint and completion (3 and 6 weeks post-randomization, respectively), and at 4 weeks post-discharge. Assessments will focus on drug craving, mood, stress, motivation/self-efficacy, and physical health and well being. The investigators hypothesize that women in the BI group will complete more treadmill sessions and spend more time treadmill walking than those in the C group. As a Stage 1b therapy development RCT, study data will be used for effect size estimation in preparation for Stage 2 RCT. This dissertation proposal will provide benchmark data on the utility of BI for promoting physical activity. Further, it will promote exercise compliance, allowing scientists to better evaluate potential benefits of physical activity on treatment outcomes in women with SUDs.

Being tested
Behavioral Incentives, Education Control
Keywords
substance use, drug use, drug abuse, exercise, physical activity
Medical subject headings
Cocaine-Related Disorders, Substance-Related Disorders, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral IncentivesBehavioural

    Vouchers for complying with target behavior of treadmill walking

  • Education ControlBehavioural

    Education class

Study groups in NCT01283191
Study groupRoleWhat they receive
Behavioral IncentivesExperimentalVouchers for complying with target behavior
Receives: Behavioral: Behavioral Incentives
Education ControlPlacebo comparatorEducation class
Receives: Behavioral: Education Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time in core sessions

    Time (minutes) spent treadmill walking over 18 core sessions

    Measured: 6 weeks

  2. Total time

    Total time (minutes) spent treadmill walking over the 6 week study period (core sessions + additional sessions)

    Measured: 10 weeks

Secondary outcomes (9)
  1. Higher intensity time

    Time (minutes) spent in higher intensity physical activity over 18 core sessions

    Measured: 6 weeks

  2. Higher intensity total time

    Total time (minutes) spent in higher intensity physical activity over the 6 week study period

    Measured: 6 weeks

  3. Session number

    Number of 30-minute treadmill sessions completed

    Measured: 6 weeks

  4. Total session number

    Number of total treadmill sessions (any duration)

    Measured: 6 weeks

  5. Number of moderate sessions

    Number of treadmill sessions at moderate intensity exercise

    Measured: 6 weeks

  6. Total walking time

    Total time walking on treadmill

    Measured: 6 weeks

  7. Consecutive exercise sessions

    Number of consecutive exercise sessions completed (3 days/week X 6 weeks)

    Measured: 6 weeks

  8. Post-discharge exercise

    Quantity and frequency of exercise during 4-week post-discharge follow-up

    Measured: 4 weeks

  9. Relapse to drug use

    Relapse to cocaine and other drug use post discharge

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2011 (estimated)
  2. Study startMay 2012
  3. Primary completionAug 2013
  4. Study completionAug 2013

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
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01283191
Sponsor's protocol ID
PD301598 1R36DA030619-01
Other IDs
R36DA030619
Status last verified
Dec 2014
First submitted
24 Jan 2011
Last updated
18 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Incentives in people with Cocaine Dependence, run by Virginia Commonwealth University at 1 site 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 5 inclusion and 2 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 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Time in core sessions (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 18 Dec 2014.

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