Clinical trial NCT02696096: Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Official title: Neuroimaging Predictors of Relapse During Treatment for Opiate Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid Addiction
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study proposes to use functional magnetic resonance imaging (FMRI) to observe brain activity and behavior associated with decision-making about rewards (DD task), working memory and working memory cognitive persistence (WM task), and craving (CR task) in 72 opiate dependent participants initiating buprenorphine. While stably using opiates (initial study appointment) and again during withdrawal (approximately 3 days later), participants will receive an FMRI scan with behavioral challenges; immediately after the second FMRI, they will receive their first dose of buprenorphine. Buprenorphine treatment will continue for twelve weeks, followed by a four week taper. Urine toxicological analysis will be performed prior to the first scanning session, weekly for two weeks and biweekly thereafter.

Participation for all individuals will last 4 months. Assessments will occur at baseline, and weeks 1, 2, 4, 8, and 12. Buprenorphine induction will begin at the completion of the second scan; follow-up medical visits will align with study assessments on weeks 1, 2, 4, 8 and 12. All participants will receive 16 weeks of buprenorphine (the final 4 of these 16 weeks will include a taper).


Eligibility criteria: Inclusion Criteria:

* opiate dependent persons
* 21-50 years old
* interested in initiating outpatient buprenorphine treatment

Exclusion Criteria:

* current methadone maintenance treatment program participation
* medically necessary prescription opiate treatment (e.g., for chronic pain)
* current criteria for a DSM-V diagnosis of substance dependence for sedative or hypnotic drugs, alcohol, stimulants, cocaine, inhalants, hallucinogens
* diagnosis of organic brain disorder, bipolar disorder, schizophrenia, schizo-affective, schizophreniform or paranoid disorder
* current suicidality on the Modified Scale for Suicidal Ideation
* evidence of neuropsychological dysfunction as assessed by the study physician with confirmation with the Folstein Mini-Mental Status Examination•
* anticipated major painful event (significant surgical procedure) in the coming 4 months
* probation or parole requirements or an upcoming move that might interfere with protocol participation
* history of allergic reaction to buprenorphine or naloxone
* currently pregnant or planning to become pregnant in the next 4 months
* history of neurological disorder (e.g., epilepsy, stroke, brain injury)
* impaired uncorrected vision
* FMRI contraindications (e.g., claustrophobia, specific metallic implants and injuries)

Primary outcomes:
measure: Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category
timeFrame: Baseline and 1 week
measure: Working Memory - Between Groups at Baseline by Lapsed Category
timeFrame: Baseline
measure: Changes in Working Memory - Within Groups During Satiation and Withdrawal
timeFrame: Baseline and 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
References: