NCT01924468

Brain Networks and Addiction Susceptibility

Completed Phase 1 Last updated 16 May 2019

What this trial tests

Phase 1 trial testing Oral methylphenidate and Oral haloperidol in Nicotine Dependence in 76 participants. Completed in 14 May 2019.

Timeline

14 August 2013

Primary endpoint
5 September 2018

14 May 2019

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Primary purpose	prevention
Enrollment	76
Start date	14 August 2013
Primary completion	5 September 2018
Estimated completion	14 May 2019
Sites	1 location across United States

Drugs / interventions tested

• Oral methylphenidate and Oral haloperidol — full drug profile →

Conditions studied

• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 18 to 55, any sex, with Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- The risk for becoming addicted to drugs varies from person to person, even among those using similar drugs in a similar way. Researchers do not fully understand why some people become addicted to drugs and others do not. Studies suggest that under certain life circumstances, some genes may increase the risk for addiction. This study will use genetic information, computer tasks, magnetic resonance imaging (MRI), and other tests to see what brain networks may be related to drug addiction.

Objectives:

\- To better understand brain networks that may be related to susceptibility to drug addiction.

Eligibility:

\- Healthy non-smoking volunteers between 18 and 55 years of age.

Design:

* This study will have one screening visit and four all-day study visits. For male participants, the visits will be about 7 days apart over 5 to 7 weeks. Female participants will have the visits scheduled to coordinate with their menstrual cycle.
* This study involves small doses of three approved drugs: two oral dopamine drugs and a nicotine patch. For each scanning session, participants will have three study drugs. However, only one pill or patch will be the real drug; the other two will be placebos. Some participants may have only placebos during a visit.
* Participants will be screened with a physical exam and medical history. Blood and urine samples will be taken. Other tests will be given to ensure that participants are not smoking or using drugs while they are in the study.
* During the all-day scanning visits, participants will receive two pills and one patch in the morning and they will be trained on simple computer tasks. In the afternoon, participants will have MRI scans and we will measure their brain activity while they rest and while they perform computer tasks in the scanner. Participants will also answer questionnaires during the scanning visits.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Catecholaminergic Modulation of Large-Scale Network Dynamics Is Tied to the Reconfiguration of Corticostriatal Connectivity.
   Hill JA, Korponay C, Salmeron BJ, Ross TJ, et al · · 2024 · cited 3× · PMID 39665506 · DOI 10.1002/hbm.70086
2. Functional Magnetic Resonance Imaging Signal Typically Viewed as "Noise" Has Clinical Relevance in Psychiatry.
   Welsh JC, Korponay C, Zhai T, Hill JA, et al · · 2026 · PMID 42005285 · DOI 10.1016/j.bpsgos.2026.100720