Cognitive Enhancement and Relapse Prevention in Cocaine Addiction

Cocaine Addiction Clinical Trial

Official title:

The Clinical and Neural Response of Cocaine Addicts to Combination Treatment With a Cognitive Enhancer and Extinction-Based Psychotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067846
• Other study ID #: 111989
• Secondary ID: R21DA025243
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: October 31, 2013
• Start date: June 2010
• Est. completion date: January 2012

Study information

• Verified date: October 2013
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

For this project, the investigators are interested in exploring a new way to extend and maintain drug abstinence in people who are addicted to crack cocaine. This study will combine a medication called D-Cycloserine (DCS) and weekly cognitive behavioral therapy (CBT) to assess whether the combination will enhance people's ability to stay clean (drug free) for longer periods of time.

One of the greatest risks for drug relapse is drug craving. Oftentimes drug craving occurs when a person is confronted with stressors and reminders of past drug use behavior. DCS has been shown to enhance the learning of new information. By administering DCS prior to learning new techniques such as how to cope with drug craving and drug-use reminders, it is possible that patients can be more successful at living a drug free life for a longer period of time.

In addition to exploring this model behaviorally, the investigators will explore changes that may occur in the brain before and after the therapy/medication intervention. A technique called MRI (Magnetic Resonance Imaging) will be used to identify areas of the brain that are being activated during an attention task. Areas of neural activation will be assessed at study entry, end of therapy (4-week endpoint) and one month following completion of the treatment program.

Description:

Primary Hypothesis:

Enhancing glutamatergic neurotransmission with DCS facilitates CBT-related relapse prevention by potentiating the behavioral and neural representation of the diminished drug motivation associated with cocaine cues.

Specific Aims:

1. Determine if the short-term oral administration of DCS relative to placebo prior to CBT sessions facilitates cocaine abstinence and functional recovery, and reduces cocaine craving in treatment-seeking cocaine addicts.

2. Determine if DCS administration relative to placebo facilitates CBT-related decreases in the behavioral and neural response to conditioned cocaine cues.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Eligible subjects must be cocaine-dependent persons between 18 and 65 years

Exclusion Criteria:

• Any current Axis-I psychiatric diagnosis other than cocaine or alcohol dependence or nicotine use

• Any current or prior neurological disease, history of a major medical illness, or current use of psychotropic medications

• Positive history of loss of consciousness of greater than 10 min

• Significant current or prior cardiovascular disease (hypertension, arrhythmias) that is not medically stable

• History of hospitalization within the previous six months for a medical illness

• Deafness, blindness or other significant sensory impairment.

• Contraindications for D-cycloserine and magnetic resonance imaging.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavior, Addictive
• Cocaine Addiction
• Cocaine-Related Disorders

Intervention

Drug:
• Seromycin (D-cycloserine, DCS)
250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.
• Placebo
Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention.

Behavioral:
• Computerized Cognitive Behavioral Therapy
All participants received Computerized Cognitive Behavioral Therapy sessions 3 times per week for 4 weeks as a drug relapse intervention.

Locations

Country	Name	City	State
United States	Psychiatric Research Institute (PRI) (Center for Addiction Research (CAR) and Brain Imaging Research Center (BIRC)) University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Abstinence During Treatment and at Follow up Visits	Percentage of the overall number of drug abstinences of participants measured by urine drug testing	Participants provided urine samples for drug testing during treatment which occurred 3 times per week for 4 weeks, at the end of treatment, and at a 1 and 2 month follow up visit	No
Primary	Treatment Retention - Number of Visits During Treatment	Number of treatment visits attended prior to discontinuation of treatment	Treatment sessions included 3 visits per week for 4 weeks	No