NCT00688805

Effects of Propranolol on Responses to Drug-Related Imagery Scripts

Terminated Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing Propranolol in Cocaine Dependence in 40 participants. Terminated before completion.

Timeline

12 December 2007

Primary endpoint
16 December 2013

16 December 2013

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	basic science
Enrollment	40
Start date	12 December 2007
Primary completion	16 December 2013
Estimated completion	16 December 2013
Sites	1 location across United States

Drugs / interventions tested

• Propranolol (propranolol) — full drug profile →
• Placebo

Conditions studied

• Cocaine Dependence — all drugs for Cocaine Dependence →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

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

Sponsor's own description

Background:

* Relapse to drug abuse is thought to result, in many cases, from exposure to cues that trigger drug-related memories or emotional associations for example, the association between the sight of a crack pipe and a set of responses such as rapid heartbeat and desire for cocaine. This type of memory is reconsolidated (actively re-stored) each time it is reactivated; however, the reconsolidation process can be disrupted by the drug propranolol, which weakens the link between that memory and an emotional response.
* Propranolol is traditionally used to treat high blood pressure and other heart-related conditions. Researchers are interested in studying whether propranolol disrupts reconsolidation of drug-cued memories in individuals who are addicted to cocaine.

Objectives:

\- To examine whether propranolol can interfere with reconsolidation of cocaine-related memories and reduce cravings and drug use in substance abusers.

Eligibility:

\- Individuals between 18 and 55 years of age who are current cocaine users enrolled in a methadone treatment program.

Design:

* The study will involve four long sessions (visits 1, 4, 6, and 14) and 10 short sessions. The short visits will be for monitoring of participants use of drugs and alcohol; the longer visits will involve more tests and lab sessions. Participants will be randomized to either the propranolol or placebo group.
* The long sessions will involve the following procedures:
* An interview session to develop a personalized drug script/cue set.
* A two-hour intervention session with baseline measures, drug administration (propranolol or placebo), and two script-guided imagery sets. This is the only administration of propranolol during the study.
* Two follow-up test sessions, 1 and 5 weeks after the intervention session.
* Participants will make brief visits to our outpatient clinic for twice-weekly monitoring of ongoing drug use via urine screens and self-report, starting 1 week before the intervention session and ending 5 weeks later.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Prereactivation Propranolol on Cocaine Craving Elicited by Imagery Script/Cue Sets in Opioid-dependent Polydrug Users: A Randomized Study.
   Jobes ML, Aharonovich E, Epstein DH, Phillips KA, et al · · 2015 · cited 22× · PMID 26501788 · DOI 10.1097/adm.0000000000000169