Understanding Drug Abuse Treatment Outcomes

NCT01678833 | Completed

• 2 other identifiers: 99991248012-DA-N480
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Drug Abuse/Dependence

Keywords

Drug Abuse/Dependence

Outcome Measures

Primary Outcomes (1)

• 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).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Right-handed individuals between the ages of 18 and 60;
• Good physical condition;
• 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);
• Heroin or other opioid dependent;
• Suitable for MRI scanning;

You may not qualify if:

• Participants will be excluded from this study if they:
• 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.
• Are HIV infected.
• 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.
• Have current suicidal ideation.
• Are unable to undergo MRI scanning due to metallic devices in the body including dental braces, claustrophobia or body morphometry.
• Are currently using respiratory, cardiovascular or anticonvulsant medications that may interfere with the BOLD MRI signal.
• Cognitively impaired;
• 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.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (2)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

University of Maryland

Baltimore, Maryland, United States

Location

Related Publications (3)

• Apodaca TR, Miller WR. A meta-analysis of the effectiveness of bibliotherapy for alcohol problems. J Clin Psychol. 2003 Mar;59(3):289-304. doi: 10.1002/jclp.10130.

  PMID: 12579546 BACKGROUND

• Aharonovich E, Hasin DS, Brooks AC, Liu X, Bisaga A, Nunes EV. Cognitive deficits predict low treatment retention in cocaine dependent patients. Drug Alcohol Depend. 2006 Feb 28;81(3):313-22. doi: 10.1016/j.drugalcdep.2005.08.003. Epub 2005 Sep 19.

  PMID: 16171953 BACKGROUND

• Aharonovich E, Brooks AC, Nunes EV, Hasin DS. Cognitive deficits in marijuana users: Effects on motivational enhancement therapy plus cognitive behavioral therapy treatment outcome. Drug Alcohol Depend. 2008 Jun 1;95(3):279-83. doi: 10.1016/j.drugalcdep.2008.01.009. Epub 2008 Mar 7.

  PMID: 18329188 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elliot Stein, Ph.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: July 19, 2012
• Study Completion: March 7, 2016
• Last Updated: April 5, 2018

Record last verified: 2016-03-07

Locations

US (2)