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Behavioral Incentives to Increase Exercise in Cocaine Dependent Women

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Incentives
Education Control
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring substance use, drug use, drug abuse, exercise, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Rubicon, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Behavioral Incentives

Education Control

Arm Description

Vouchers for complying with target behavior

Education class

Outcomes

Primary Outcome Measures

Time in core sessions
Time (minutes) spent treadmill walking over 18 core sessions
Total time
Total time (minutes) spent treadmill walking over the 6 week study period (core sessions + additional sessions)

Secondary Outcome Measures

Higher intensity time
Time (minutes) spent in higher intensity physical activity over 18 core sessions
Higher intensity total time
Total time (minutes) spent in higher intensity physical activity over the 6 week study period
Session number
Number of 30-minute treadmill sessions completed
Total session number
Number of total treadmill sessions (any duration)
Number of moderate sessions
Number of treadmill sessions at moderate intensity exercise
Total walking time
Total time walking on treadmill
Consecutive exercise sessions
Number of consecutive exercise sessions completed (3 days/week X 6 weeks)
Post-discharge exercise
Quantity and frequency of exercise during 4-week post-discharge follow-up
Relapse to drug use
Relapse to cocaine and other drug use post discharge

Full Information

First Posted
January 24, 2011
Last Updated
December 16, 2014
Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01283191
Brief Title
Behavioral Incentives to Increase Exercise in Cocaine Dependent Women
Official Title
Using Behavioral Incentives to Promote Exercise Compliance in Cocaine Dependent Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
substance use, drug use, drug abuse, exercise, physical activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Incentives
Arm Type
Experimental
Arm Description
Vouchers for complying with target behavior
Arm Title
Education Control
Arm Type
Placebo Comparator
Arm Description
Education class
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Incentives
Intervention Description
Vouchers for complying with target behavior of treadmill walking
Intervention Type
Behavioral
Intervention Name(s)
Education Control
Intervention Description
Education class
Primary Outcome Measure Information:
Title
Time in core sessions
Description
Time (minutes) spent treadmill walking over 18 core sessions
Time Frame
6 weeks
Title
Total time
Description
Total time (minutes) spent treadmill walking over the 6 week study period (core sessions + additional sessions)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Higher intensity time
Description
Time (minutes) spent in higher intensity physical activity over 18 core sessions
Time Frame
6 weeks
Title
Higher intensity total time
Description
Total time (minutes) spent in higher intensity physical activity over the 6 week study period
Time Frame
6 weeks
Title
Session number
Description
Number of 30-minute treadmill sessions completed
Time Frame
6 weeks
Title
Total session number
Description
Number of total treadmill sessions (any duration)
Time Frame
6 weeks
Title
Number of moderate sessions
Description
Number of treadmill sessions at moderate intensity exercise
Time Frame
6 weeks
Title
Total walking time
Description
Total time walking on treadmill
Time Frame
6 weeks
Title
Consecutive exercise sessions
Description
Number of consecutive exercise sessions completed (3 days/week X 6 weeks)
Time Frame
6 weeks
Title
Post-discharge exercise
Description
Quantity and frequency of exercise during 4-week post-discharge follow-up
Time Frame
4 weeks
Title
Relapse to drug use
Description
Relapse to cocaine and other drug use post discharge
Time Frame
10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leila Z Islam, M.S.
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rubicon, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States

12. IPD Sharing Statement

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Behavioral Incentives to Increase Exercise in Cocaine Dependent Women

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