Understanding Drug Abuse Treatment Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01678833
First received: August 31, 2012
Last updated: June 19, 2014
Last verified: May 2014
  Purpose

Background:

Although some treatments for substance abuse are considered effective for some people who are drug dependent, many others do not benefit as much over time. Researchers are working to find out what characteristics predict treatment response. They also want to determine how to design treatments that are more effective for a greater number of substance abusers. This pilot study involves providing drug addicts with cognitive behavioral therapy (CBT), a treatment considered to be one of the most effective in reducing substance-abuse, to identify ways in which the brain works that may predict and explain treatment effects. A comparison group will be included that receives only standard psychotherapy or talk therapy. This approach will enable researchers to determine what factors might be interfering with favorable treatment outcomes and how to refine or develop new treatments that work well for more people.

Objectives:

- To identify individual characteristics which predict and explain the effects of CBT in people with opiate dependence.

Eligibility:

  • Males between 18 and 60 years of age who are dependent on opioids (such as heroin).
  • Participants must be willing to take buprenorphine and receive substance abuse counseling.

Design:

  • Participants will be screened with a physical exam and medical history.
  • Researchers will ask questions about participants ability to cope in certain situations, along with questions about drug use and lifestyle issues. These questions will be asked twice, before and after completing treatment.
  • Participants will be placed into one of two groups. One group will have CBT twice a week for 8 weeks. The other group will have standard counseling twice per week. Both groups will take buprenorphine as part of the drug abuse treatment.
  • Participants will have other tests during this study. They will have imaging studies to look at brain function. These studies will test thinking and decision making.

Condition
Drug Abuse/Dependence

Study Type: Observational
Official Title: Neural Mechanistic Explanations for Differential Drug Abuse Treatment Outcomes

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The focus of our outcome evaluation will be use of opioid (e.g., frequency, days of continuous abstinence, etc.), coping strategies, and change in lifestyle measures (e.g., employment, relationships, behavioral problems, treatment engagement).

Estimated Enrollment: 18
Study Start Date: July 2012
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Participants will be eligible for inclusion in the study if they meet the following criteria:

  1. Right-handed individuals between the ages of 18 and 60;
  2. Good physical condition;
  3. Participating and receiving buprenorphine treatment in protocol 09-DA-N020, a study being conducted in the NIDA Intramural Archway Clinic (Dr. Kenzie Preston, PI) in Baltimore, MD OR at outpatient treatment facilities at UMMC (ADAP or OATS);
  4. Heroin or other opioid dependent;
  5. Suitable for MRI scanning;

EXCLUSION CRITERIA:

Participants will be excluded from this study if they:

  1. History of neurological illnesses including but not limited to CVA, CNS tumor, head trauma, MS or other demyelinating diseases, epilepsy, movement disorders, or migraine in treatment.
  2. Are HIV infected.
  3. Have deep vein thrombosis (DVT): Assessment tool: self report during H& P of thrombosis, family history of thrombosis, or a medical condition that may lead to a hypercoagulable state Rationale: Lying still for an hour (plus the mock scanning session) may be a risk for the development of DVT in persons with certain medical conditions. As such, persons with will be excluded.
  4. Have current suicidal ideation.
  5. Are unable to undergo MRI scanning due to metallic devices in the body including dental braces, claustrophobia or body morphometry.
  6. Are currently using respiratory, cardiovascular or anticonvulsant medications that may interfere with the BOLD MRI signal.
  7. Cognitively impaired;
  8. Continued noncompliance (after the 3rd time) with respect to testing positive for illicit drugs or reporting caffeine use in the past 12 hours or alcohol use in the past 24 hours when they visit for their scanning sessions will lead to discontinuing their participation in the #480 protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678833

Contacts
Contact: Emma Jane Rose, Ph.D. Not Listed emmajanerose@gmail.com
Contact: Elliot Stein, Ph.D. (443) 740-2650 estein@mail.nih.gov

Locations
United States, Maryland
National Institute on Drug Abuse Recruiting
Baltimore, Maryland, United States, 21224
Contact: For more information contact Mathew's Media Group Recruiting    800-535-8254    researchstudies@mail.nih.gov   
University of Maryland Recruiting
Baltimore, Maryland, United States
Sponsors and Collaborators
Investigators
Principal Investigator: Elliot Stein, Ph.D. National Institute on Drug Abuse (NIDA)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01678833     History of Changes
Other Study ID Numbers: 999912480, 12-DA-N480
Study First Received: August 31, 2012
Last Updated: June 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Drug Abuse/Dependence

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014