Understanding Drug Abuse Treatment Outcomes

Completed

Conditions studied: Drug Abuse/Dependence

In brief

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.

Key facts

Study ID

NCT01678833

Run by

National Institute on Drug Abuse (NIDA)

People needed

7

Starts

2012-07-19

Expected to finish

2016-03-07

Last updated by the study team

2018-04-05

Who can join

Age: 18 and older, up to 60. Sex: male. Healthy volunteers: accepted.

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.

Where it is running

• National Institute on Drug Abuse — Baltimore, Maryland, United States
• University of Maryland — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.