Cannabis Dependence Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of Lofexidine and Dronabinol for the Treatment of Marijuana Dependence
The purpose of this study is to see if Lofexidine in combination with Marinol is superior to placebo in achieving abstinence, reducing cannabis use and reducing withdrawal in cannabis-dependent patients seeking treatment for their marijuana use.
Cannabis use disorders remain the most common illicit drug use disorder and options for treatment remain limited. Compared to other abusable substances, there has been little investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy for cannabis dependence has yet to been developed. The development of effective cannabis dependence pharmacotherapy is an important unmet public health need. Agonist pharmacotherapy strategies have been effective for other substance use disorders (e.g., opioid and nicotine use disorders) and the endocannabinoid system represents a promising target for agonist pharmacotherapy with dronabinol. Lofexidine, a noradrenergic system suppressant, is effective in treating opioid withdrawal and shows promise as a cannabis use disorder pharmacotherapy. Haney et al. (2008) found that the combination of lofexidine and dronabinol (Lofex-Dro) was superior to placebo, lofexidine alone, or dronabinol alone in improving sleep and other cannabis withdrawal symptoms. Further, reduction in craving and relapse was greater for this combined pharmacotherapy relative to either medication alone or placebo. The proposed protocol is a 2 group, double blind, placebo-controlled outpatient study of the safety and efficacy of the combination of dronabinol and lofexidine for the treatment of cannabis dependence. We plan to enroll 180 subjects in a 12-week trial. The primary hypothesis is that dronabinol will act as an agonist treatment while lofexidine will suppress craving- and cue-induced related stress such that the combination will act in a complementary manner to induce prolonged abstinence from marijuana. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01005810 -
A Trial of N-Acetylcysteine (an Over-the-Counter Medicine) in Adolescents Who Smoke Marijuana
|
Phase 2 | |
Completed |
NCT00114439 -
Lithium Cannabis Withdrawal Study
|
Phase 2 | |
Completed |
NCT00350285 -
The Teen Marijuana Check-Up
|
Phase 2 | |
Completed |
NCT01618656 -
Safety and Efficacy of a FAAH-Inhibitor to Treat Cannabis Withdrawal
|
Phase 2 | |
Completed |
NCT01153490 -
Improving Substance Use and Clinical Outcomes in Heavy Cannabis Users With Quetiapine
|
Phase 4 | |
Completed |
NCT02946489 -
Facilitating the Behavioral Treatment of Cannabis Use Disorder
|
Phase 1 | |
Completed |
NCT02088177 -
Study of Long-Acting Injectable Naltrexone to Treat Cannabis Dependence
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT01565174 -
The Pharmaco-genetic and Brain Mechanisms Associated With Cannabis- Induced Psychosis
|
N/A | |
Completed |
NCT01697709 -
Quetiapine Pharmacotherapy for Cannabis Dependence
|
Phase 2 | |
Recruiting |
NCT04721353 -
Reducing Cannabis Overuse With Prazosin
|
Phase 4 | |
Completed |
NCT01603992 -
Quiting Marijuana Use: Self-report Study of Quitting Straegies and Withdrawal Symptoms
|
||
Completed |
NCT00167297 -
Atomoxetine for the Treatment of Cannabis Dependence
|
Phase 2 | |
Terminated |
NCT01598896 -
Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia
|
Phase 2/Phase 3 | |
Completed |
NCT01611948 -
Treatment for Cannabis Withdrawal and Dependence
|
Phase 2 | |
Recruiting |
NCT03221231 -
N-acetylcysteine for the Treatment of Cannabis Dependence: Working Mechanisms
|
Phase 4 | |
Not yet recruiting |
NCT03366909 -
Mindfulness Meditation and Cannabis Dependence : Therapy Effectiveness
|
N/A | |
Completed |
NCT01639872 -
Clozapine for Cannabis Use in Schizophrenia
|
Phase 4 | |
Not yet recruiting |
NCT06334016 -
Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
|
Early Phase 1 | |
Completed |
NCT01793961 -
Effects of Chronic Intake of Cannabis on Contrast Sensitivity
|
N/A | |
Completed |
NCT01834794 -
Targeting Tobacco Cessation During Treatment for Cannabis Use Disorders
|
N/A |