Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia &

Status Completed

Clinical Trial Summary

It is known, that a so called "pain memory" usually evolves in chronic pain syndromes which both aggravates the disorder and modifies the patients pain perception. Thus, the principal object of pain therapy is to "delete" this dysfunctional pain memory. The combination of medication, physiotherapy and psychological therapy seems to be the most effective treatment. This study investigates the effect of a concomitant Dronabinol medication (Cannabinoid) on the effectiveness of behavioral therapy. It is hypothesized that the combination of behavioral therapy and Dronabinol will be most effective in deleting the pain memory.

Clinical Trial Description

This study investigates the combination of operant behavioral treatment and Cannabinoid medication in patients with fibromyalgia and patients with back pain. It is well known that cannabinoids (THC) accelerate learning processes. It is assumed that the combination of both treatments may exert an synergetic effect. A low dose of THC is used, which ist not expected to have direct analgetic effects. The study also investigates genetic determinants of both disorders and the response to treatment, respectively.

The patients will be randomly assigned to one of four groups: Behavioral therapy and Dronabinol, behavioral therapy and placebo, behavioral therapy only, standard medical therapy. Patients will attend 12 weekly group-sessions (6-8 patients) of behavioral therapy. Behavioral therapy sessions will include training in reducing pain behaviour and establishing active and "healthy" behaviour instead. There will be weekly medical safety visits, in which the patients receive medication and undergo a physical examination (blood and urine samples).

Patients will be evaluated before and after behavioral therapy and will be followed for an additional 6- and 12-months phase. The outcome variables will be recorded by the use of interviews and questionnaires. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00176163
Study type	Interventional
Source	Heidelberg University
Contact
Status	Completed
Phase	Phase 2
Start date	August 2005
Completion date	May 2009

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05659862` - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia	N/A
Recruiting	`NCT03207828` - Testing Interventions for Patients With Fibromyalgia and Depression	N/A
Completed	`NCT03042728` - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program	N/A
Recruiting	`NCT06097091` - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia	N/A
Recruiting	`NCT04554784` - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia	N/A
Completed	`NCT03300635` - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia	N/A
Recruiting	`NCT06166563` - Exercise, Irritable Bowel Syndrome and Fibromyalgia	N/A
Completed	`NCT03227952` - Sensory Stimulation in Fibromyalgia	N/A
Completed	`NCT03166995` - Postural Exercises in Women With Fibromyalgia	N/A
Recruiting	`NCT06237595` - Vagus Nerve Stimulation in Fibromyalgia	N/A
Completed	`NCT01888640` - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)	N/A
Completed	`NCT03641495` - Pain Education and Therapeutic Exercise for Fibromyalgia	N/A
Recruiting	`NCT05581628` - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting	`NCT05128162` - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia	Phase 2
Completed	`NCT04674878` - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia	N/A
Active, not recruiting	`NCT04084795` - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia	N/A
Completed	`NCT03129906` - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients	N/A
Completed	`NCT05058911` - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia	N/A
Recruiting	`NCT04571853` - New Educational Tool for FM	N/A
Recruiting	`NCT04571528` - Effectiveness of VIRTUAL FIBROWALK STUDY	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms